DLRC Directors Kevin Judges and Dianne Lee meet The Queen
DLRC wins Queen's Award for Enterprise: International Trade
DLRC wins Employer of the Year in the 2016 Hertfordshire Business Awards
Dianne Lee wins the TOPRA Inspiration Award 2016
Michelle- 5 years at DLRC
BREXIT – How will this affect registration procedures and the approval of new medicines in the UK and in the EU?
Launch of PRIME and EMA review - UPDATE June 2016
Annual European Medicines Agency Review of the Year and Outlook for 2016
The New Clinical Trial Regulation: What Should We Expect?
Starting at DLRC - Katherine's story - UPDATE June 2016

DLRC Directors Kevin Judges and Dianne Lee meet The Queen

Following on from winning a Queen’s Award for Enterprise, Dianne and Kevin were invited to a reception at Buckingham Palace. There they had the opportunity to meet with Her Majesty The Queen, and enjoyed a brief conversation.


Dianne said that she was very impressed by The Queen. “She’s an amazing person. Having already attended two engagements during the day, she then met a couple of hundred business leaders and was able to engage on many levels, and seemed interested in everything we do.”


The evening reception was hosted by Her Majesty and was attended by other members of the Royal Family: The Duke of Edinburgh, The Duke and Countess of Wessex, The Princess Royal, and The Duke of Kent. It was held in the opulent state rooms of the palace with views over the beautiful gardens. Kevin and Dianne were greeted with champagne and canapés, and mingled with other Queen's Awards winners before meeting members of the Royal Family.


Later in the year the Lord Lieutenant of Hertfordshire is due to present the Queen’s Award crystal bowl to the company, and representatives of DLRC will be attending a celebratory dinner hosted by the Institute of Export and Overseas Trade at the Royal Horseguards Hotel in London.

DLRC wins Queen's Award for Enterprise: International Trade

DLRC is proud to announce that it has been named the winner of a 2017 Queen’s Award for Enterprise, in recognition of its exceptional international business.


A Queen’s Award for Enterprise is the highest honour that can be bestowed on a UK company. The winning organisations are recommended for the awards by the Prime Minister and are then approved by Her Majesty The Queen. Each year, the announcement of the winners is made on 21st April, the Queen’s birthday. DLRC was chosen for an award in International Trade in recognition of its substantial year-on-year growth in overseas sales over a six-year period. In addition, the company demonstrated the vision and strategies which it has employed in order to achieve this success.


“Winning the Queen’s Award is a tremendous accolade for DLRC and we are extremely proud to receive it,” said Kevin Judges, Director and joint business owner. “Over the six-year period that formed the basis for this award, our turnover increased four-fold and our overseas sales by a factor of six. Everyone in the organisation has worked so hard to achieve this level of business expansion and it’s great that their efforts are now being recognised with this prestigious honour.”


The 2017 Queen’s Awards for Enterprise are being given for the highest levels of excellence demonstrated in each of four categories; International Trade, Innovation, Sustainable Development and Promoting Opportunity (through social mobility). DLRC’s award for International Trade reflects the continuous expansion of its work with companies overseas and with government regulatory bodies here and abroad.


As a Queen’s Award winner, DLRC will receive an invitation to attend a reception at Buckingham Palace with H.M. The Queen later in the year. It will also be presented with a commemorative crystal bowl by the Queen’s representative, the Lord Lieutenant of Hertfordshire, in a separate ceremony, and will be permitted to use the Queen’s Award Emblem for five years as a symbol of the company’s success.


Dianne Lee, DLRC Founder and Director, is thoroughly delighted with the announcement. She said, “We are immensely proud that we play a part in the development of important medicines for patients. This award acknowledges the dedication and performance of our highly skilled team, and reinforces my belief that employing great people is step-one on the way to business success.”


Last year DLRC was awarded the Employer of the Year by the Hertfordshire Business Awards, and Dianne Lee also received the 2016 Inspiration Award from TOPRA, the regulatory affairs professional body.


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DLRC wins Queen's Award for Enterprise: International Trade

DLRC is proud to announce that it has been named the winner of a 2017 Queen’s Award for Enterprise, in recognition of its exceptional international business.


A Queen’s Award for Enterprise is the highest honour that can be bestowed on a UK company. The winning organisations are recommended for the awards by the Prime Minister and are then approved by Her Majesty The Queen. Each year, the announcement of the winners is made on 21st April, the Queen’s birthday. DLRC was chosen for an award in International Trade in recognition of its substantial year-on-year growth in overseas sales over a six-year period. In addition, the company demonstrated the vision and strategies which it has employed in order to achieve this success.


“Winning the Queen’s Award is a tremendous accolade for DLRC and we are extremely proud to receive it,” said Kevin Judges, Director and joint business owner. “Over the six-year period that formed the basis for this award, our turnover increased four-fold and our overseas sales by a factor of six. Everyone in the organisation has worked so hard to achieve this level of business expansion and it’s great that their efforts are now being recognised with this prestigious honour.”


The 2017 Queen’s Awards for Enterprise are being given for the highest levels of excellence demonstrated in each of four categories; International Trade, Innovation, Sustainable Development and Promoting Opportunity (through social mobility). DLRC’s award for International Trade reflects the continuous expansion of its work with companies overseas and with government regulatory bodies here and abroad.


As a Queen’s Award winner, DLRC will receive an invitation to attend a reception at Buckingham Palace with H.M. The Queen later in the year. It will also be presented with a commemorative crystal bowl by the Queen’s representative, the Lord Lieutenant of Hertfordshire, in a separate ceremony, and will be permitted to use the Queen’s Award Emblem for five years as a symbol of the company’s success.


Dianne Lee, DLRC Founder and Director, is thoroughly delighted with the announcement. She said, “We are immensely proud that we play a part in the development of important medicines for patients. This award acknowledges the dedication and performance of our highly skilled team, and reinforces my belief that employing great people is step-one on the way to business success.”


Last year DLRC was awarded the Employer of the Year by the Hertfordshire Business Awards, and Dianne Lee also received the 2016 Inspiration Award from TOPRA, the regulatory affairs professional body.


website_QA_banner_copy.gif

DLRC wins Queen's Award for Enterprise: International Trade

DLRC is proud to announce that it has been named the winner of a 2017 Queen’s Award for Enterprise, in recognition of its exceptional international business.


A Queen’s Award for Enterprise is the highest honour that can be bestowed on a UK company. The winning organisations are recommended for the awards by the Prime Minister and are then approved by Her Majesty The Queen. Each year, the announcement of the winners is made on 21st April, the Queen’s birthday. DLRC was chosen for an award in International Trade in recognition of its substantial year-on-year growth in overseas sales over a six-year period. In addition, the company demonstrated the vision and strategies which it has employed in order to achieve this success.


“Winning the Queen’s Award is a tremendous accolade for DLRC and we are extremely proud to receive it,” said Kevin Judges, Director and joint business owner. “Over the six-year period that formed the basis for this award, our turnover increased four-fold and our overseas sales by a factor of six. Everyone in the organisation has worked so hard to achieve this level of business expansion and it’s great that their efforts are now being recognised with this prestigious honour.”


The 2017 Queen’s Awards for Enterprise are being given for the highest levels of excellence demonstrated in each of four categories; International Trade, Innovation, Sustainable Development and Promoting Opportunity (through social mobility). DLRC’s award for International Trade reflects the continuous expansion of its work with companies overseas and with government regulatory bodies here and abroad.


As a Queen’s Award winner, DLRC will receive an invitation to attend a reception at Buckingham Palace with H.M. The Queen later in the year. It will also be presented with a commemorative crystal bowl by the Queen’s representative, the Lord Lieutenant of Hertfordshire, in a separate ceremony, and will be permitted to use the Queen’s Award Emblem for five years as a symbol of the company’s success.


Dianne Lee, DLRC Founder and Director, is thoroughly delighted with the announcement. She said, “We are immensely proud that we play a part in the development of important medicines for patients. This award acknowledges the dedication and performance of our highly skilled team, and reinforces my belief that employing great people is step-one on the way to business success.”


Last year DLRC was awarded the Employer of the Year by the Hertfordshire Business Awards, and Dianne Lee also received the 2016 Inspiration Award from TOPRA, the regulatory affairs professional body.


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DLRC wins Employer of the Year in the 2016 Hertfordshire Business Awards

DLRC is extremely proud to have been crowned the 2016 Hertfordshire Business Awards Employer of the Year.


The award was announced and presented at a prestigious ceremony at Knebworth House in Hertfordshire on Thursday 24th November, attended by a contingent from the DLRC team and over 400 local business people.


The judges were impressed with the flexible working arrangements offered to staff, the commitment to supporting professional development and the social aspects of the work environment. They also praised the way the company works to ensure clients get the best service by matching the right people to projects in terms of experience.


DLRC founder Dianne Lee was particularly pleased to receive the award. It was, she said, a great endorsement of the aims and achievements of the company in providing the best possible employment for regulatory professionals.


She was also keen to point out that the awards success was down to DLRC staff. “We're delighted to win this award because our approach to running DLRC is only made possible by the dedication and hard work of our employees. Many of them have family commitments and their valuable input into the development of new medicines would be lost if they couldn't have flexible working arrangements.”


Dianne went on to explain that in a complex and ever-evolving industry, it was crucial that the team kept up-to-date with changes in legislation and best practice. The company’s commitment to training and knowledge sharing was essential to provide the quality of support that clients expected, and this had been recognised by the judging panel, she said.


DLRC Director Kevin Judges was also thrilled to receive the award, and commented, “It’s fantastic to get this recognition as an employer and it’s also a great reflection on the commitment and hard work of the entire DLRC team”.


This is the second award that DLRC has won recently – Dianne also achieved individual recognition when she was presented with TOPRA’s 2016 Inspiration Award. However, she is delighted that the latest accolade reflects the efforts of the whole company. As Dianne notes, the company is working hard to create a good working environment and fantastic career opportunities, but ultimately it is DLRC’s employees who make it such a great place to work.


If you are a regulatory professional who’s interested in a great place to work, contact us here.


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Photographs courtesy Archant Limited - photographer Casey Gutteridge

Dianne Lee wins the TOPRA Inspiration Award 2016

We are extremely proud to announce that our founder and director, Dianne Lee, has won the Inspiration award in TOPRA’s Awards for Regulatory Excellence 2016.


The Inspiration Award is aimed at a person who inspires the intellect, or prompts action or innovative outcomes. It recognises exceptional contributions by an individual in inspiring fellow regulatory professionals in the development of their regulatory career, or as an inspirational team leader in a regulatory activity or project.


Dianne was nominated for the award in secret by a group comprising her work colleagues, regulatory professionals from other companies and other people who have been inspired by Dianne or who have witnessed her effect on those around her.


The nominating group was unanimous in their praise for Dianne’s approach to regulatory affairs. Their nomination stated: “An inspirational and motivational leader, Dianne has a business philosophy that encourages achievement, embraces flexible working and apportions care and attention to colleagues and business in equal measure. Dianne has created a highly successful organisation which has allowed and encouraged regulatory professionals to work in an individualised way, adapting the traditional working week to suit people with family and other external commitments.”


The prestigious annual TOPRA Awards attract a lot of nominations, and the judging committee first decides on a shortlist before eventually selecting a winner from each category. In September, Dianne was extremely surprised to be told she had been shortlisted when she had no idea she had been nominated in the first place. She then had to wait until the awards ceremony in November for the final result.


Making the award, the TOPRA judges said: “Dianne is an inspiration as a Regulatory Professional with her extensive knowledge and decades of experience across the whole product lifecycle. During the last 10 years, she has set up and continues to lead a successful and growing business; one which nurtures new graduates and veterans alike. Under Dianne’s direction the company has offered paid internships, employed students for work experience and has recruited, trained and provided ongoing mentoring for several new graduates.”


Dianne received the award at TOPRA’s gala awards evening on 2nd November 2016 at the Grand Connaught Rooms in London. Details about the awards can be found here.


If you are interested in the services that DLRC can provide, or would like to find out about the careers that we can offer, please get in touch.

Dianne Lee wins the TOPRA Inspiration Award 2016

Michelle- 5 years at DLRC

I joined DLRC in 2011 as a recent graduate with a BSc (Hons) in Biomedical Sciences. I love science but didn’t like working in the laboratory environment. So when I saw the position at DLRC advertised, even though I had no idea what regulatory affairs was, I applied. After a successful telephone interview, I had to attend for face to face interview and give a presentation on why I wanted to work within regulatory affairs. It was only once I properly started looking into regulatory affairs during the interview process that I realised what a perfect job it would be for me. I would get to work in a collaborative office environment and apply my scientific knowledge as well as project skills. I then realised how hard it was to get a job within the profession and wanted the role even more! Luckily my interview was successful and I was offered the position of Regulatory Executive.


In my 5 years of working at DLRC, I have seen the company grow a huge amount. There were only 5 regulatory employees when I started, including me. Since then we’ve moved offices twice and now employ around 20 regulatory staff. It’s been great to see the company expand with the appointment of both experienced staff and also newer graduates who are starting out in their careers. Everyone gets on well and we are all willing to help each other out with our different areas of expertise. We also have regular sharing information sessions and we have recently appointed 4 team leaders which all helps with personal development. To aid both current and new clients, we have also implemented a, “Strategic Expertise and Operational Excellence” initiative. This allows us to ensure that we continue to develop our expertise regarding regulatory strategy and operational excellence as well as ensuring that our practises and knowledge evolve and reflect current requirements and guidance.


On a personal level, my personal development has grown a huge amount with the knowledge that I’ve learnt so far. Since joining DLRC, I have worked on a large compliance project and various post marketing projects. More recently I have been working mainly within clinical development including the submission and approval of a Paediatric Investigational Plan (PIP) and multiple early and late phase clinical trial applications (CTAs). All of this experience has allowed me to see the great many aspects that Regulatory Affairs covers. I like that working for a consultancy allows me to work on very different projects for a wide range of clients while still being able to specialise in areas that I find interesting. I have been promoted twice and am now a Regulatory Project Manager. This means that I have progressed from supporting other people in a primarily operational role, to having more strategic input and managing my own projects.


As well as enjoying my current role, I have always had an interest in progressing myself academically. After working at DLRC for just over 2 years, I was given the opportunity by the company to start an MSc in Regulatory Affairs which is run by The Organisation for Professionals in Regulatory Affairs (TOPRA) and validated by the University of Hertfordshire. I was very appreciative of this sponsorship as the course is costly and requires 3 days out of the office in order to attend each module; 8 modules in total. I have now finished all 8 modules with a distinction and am planning on starting my dissertation on the Clinical Trial Regulation shortly. I have already gained a huge amount of knowledge from the MSc and have been able to apply this knowledge directly into my work. Equally, I have also been able to apply my day job into my coursework, and so the MSc has been very complimentary for my career. DLRC has really helped me achieve a lot so far within my MSc and I am excited to continue applying what I have learnt on a daily basis. I am looking forward to what the next 5 years at DLRC will bring!


If you too are interested in a career that offers varied opportunities and flexible working options, call 01462 372 472 or go to Join Us and send in a CV.

Michelle- 5 years at DLRC

I joined DLRC in 2011 as a recent graduate with a BSc (Hons) in Biomedical Sciences. I love science but didn’t like working in the laboratory environment. So when I saw the position at DLRC advertised, even though I had no idea what regulatory affairs was, I applied. After a successful telephone interview, I had to attend for face to face interview and give a presentation on why I wanted to work within regulatory affairs. It was only once I properly started looking into regulatory affairs during the interview process that I realised what a perfect job it would be for me. I would get to work in a collaborative office environment and apply my scientific knowledge as well as project skills. I then realised how hard it was to get a job within the profession and wanted the role even more! Luckily my interview was successful and I was offered the position of Regulatory Executive.


In my 5 years of working at DLRC, I have seen the company grow a huge amount. There were only 5 regulatory employees when I started, including me. Since then we’ve moved offices twice and now employ around 20 regulatory staff. It’s been great to see the company expand with the appointment of both experienced staff and also newer graduates who are starting out in their careers. Everyone gets on well and we are all willing to help each other out with our different areas of expertise. We also have regular sharing information sessions and we have recently appointed 4 team leaders which all helps with personal development. To aid both current and new clients, we have also implemented a, “Strategic Expertise and Operational Excellence” initiative. This allows us to ensure that we continue to develop our expertise regarding regulatory strategy and operational excellence as well as ensuring that our practises and knowledge evolve and reflect current requirements and guidance.


On a personal level, my personal development has grown a huge amount with the knowledge that I’ve learnt so far. Since joining DLRC, I have worked on a large compliance project and various post marketing projects. More recently I have been working mainly within clinical development including the submission and approval of a Paediatric Investigational Plan (PIP) and multiple early and late phase clinical trial applications (CTAs). All of this experience has allowed me to see the great many aspects that Regulatory Affairs covers. I like that working for a consultancy allows me to work on very different projects for a wide range of clients while still being able to specialise in areas that I find interesting. I have been promoted twice and am now a Regulatory Project Manager. This means that I have progressed from supporting other people in a primarily operational role, to having more strategic input and managing my own projects.


As well as enjoying my current role, I have always had an interest in progressing myself academically. After working at DLRC for just over 2 years, I was given the opportunity by the company to start an MSc in Regulatory Affairs which is run by The Organisation for Professionals in Regulatory Affairs (TOPRA) and validated by the University of Hertfordshire. I was very appreciative of this sponsorship as the course is costly and requires 3 days out of the office in order to attend each module; 8 modules in total. I have now finished all 8 modules with a distinction and am planning on starting my dissertation on the Clinical Trial Regulation shortly. I have already gained a huge amount of knowledge from the MSc and have been able to apply this knowledge directly into my work. Equally, I have also been able to apply my day job into my coursework, and so the MSc has been very complimentary for my career. DLRC has really helped me achieve a lot so far within my MSc and I am excited to continue applying what I have learnt on a daily basis. I am looking forward to what the next 5 years at DLRC will bring!


If you too are interested in a career that offers varied opportunities and flexible working options, call 01462 372 472 or go to Join Us and send in a CV.

BREXIT – How will this affect registration procedures and the approval of new medicines in the UK and in the EU?

The outcome of the UK’s EU referendum has resulted in many questions and speculation concerning the registration of medicines in the UK and in the EU and the effect of the UK leaving the EU will have on the regulatory processes. The UK’s Medicines and Healthcare products Regulatory Agency[1] and the European Medicines Agency (EMA)[2] have both made statements regarding the result of the referendum.


The MHRA have stated that they “will consider the implications for the work of the Agency” and “will continue to make a major contribution globally to improving public health through the effective regulation of medicines and medical devices, underpinned by science and research”.


The EMA have confirmed that “its procedures and work streams are not affected by the outcome of the referendum. The Agency will continue its operations as usual, in accordance with the timelines set by its rules and regulations”. Their remit in the protection of public health is unchanged. Importantly, the EMA have stated that they will not be drawn into speculations on the outcome of the UK leaving the EU. The EMA is a decentralised body of the EU and whilst Member States such as Denmark and Sweden have expressed an interest in hosting the Agency, the decision for a new location will be made centrally. A change in location will be well planned to minimise any effect on operation of the agency.


The UK remains a member of the EU until such time as the conclusion of the Article 50 enactment, which will take place two years after notification. Article 50 has not been notified yet as the UK Government is going through changes in its leadership and pre-notification steps (discussions in parliament; preconditions for the exit) have not been decided. EU law will apply in the UK until such time as the European Communities Act 1972 is repealed.


A steering group has been set up by the Life Sciences minister, George Freeman, to provide expertise in the negotiations for leaving the EU[3]. The chairmen of the steering group, the CEOs of GSK and AstraZeneca, will be supported by the ABPI and the BIA. Confirming that the regulatory system for medicines will remain unchanged for at least 2 years, Mr Freeman indicated that the opportunity to make changes for improvement of the system for licensing and regulating medicines would not go unnoticed.


Registration of medicines

At the time the UK joined the Common Market (the forerunner of the EU) in 1973, the UK’s Medicines Act 1968, based on Directive 65/65/EEC, the first European directive for medicinal products, had been effectively implemented. The UK’s legal system is enabling which allows for changes to be made to the legislation through Statutory Instruments without the need for Acts of Parliament. This versatility has meant that the UK has been able to amend its legislation pertaining to medicinal products in a timely and effective manner. It is noted that the UK legislation for medicinal products has followed the principles of EU legislation since 1968 and has been harmonised since 1973. There will need to be changes made to the UK legislation but these changes will be determined by the final terms for leaving the EU.


Prior to the decentralised and centralised regulatory procedures for the licensing of medicinal products, marketing authorisations were granted nationally. The outcome of the current decentralised procedures is a national licence in the Member States concerned. The outcome of the centralised procedure is a Community licence conferred by the European Commission following the recommendation for approval by the European Medicines Agency which is applicable to all countries of the EEA.


UK national licences, whether part of a decentralised regulatory procedure or not, will remain in force following leaving the EU. The status of the Community licences will have to be considered in light of the leaving terms negotiated by the UK. For example, if the UK wants to and is allowed to be a member of the European Economic Area (EEA), like Norway, the UK can retain the procedures and rules of the centralised procedure and licences will remain valid.


The legislative options if the UK is completely severed from the EU will be considered fully and the steering committee will have input into these. It is expected that future legislative changes will allow the current Community licences to be recognised rather than going through a re-evaluation process by the MHRA. However, at this time it is not possible to predict a definitive scenario.


Involvement of the MHRA in EU procedures

It is recognised that the MHRA plays a significant role in the centralised procedures for Marketing Authorisations with over a third of these having the UK as rapporteur or co-rapporteur. If the UK gains observer status with the EMA, for example through membership of the EEA, the MHRAs level of rapporteurship would not need to change nor would the membership of the various EMA committees. If the UK does not negotiate involvement in the EU regulatory procedures or is not successful in negotiations, then the MHRA will not be involved as present with the EMA. It is noted that as the Brexit has not been initiated, there is no immediate change to the current situation. The EMA has stated that it is business as usual.


Clinical Trials

The new EU Clinical Trials Regulation (2014)[4] will come into force in 2018[5]. The UK has to continue with its plans to introduce this Regulation, which is binding, until such time as the UK leaves the EU. Mr Freeman’s Accelerated Access Review project[6] will be unveiled in the autumn and this includes changes to clinical research. It will be interesting to see these proposals and to see how they fit into the framework of the Clinical Trials Regulation.


Location in the EU

Holders of a Marketing Authorisation (MAH) must be duly established in the EEA and the sponsor for an Orphan Medicinal Product must be duly established in the EU. If the UK does not have access to the EU procedures, DLRC Ltd will be able to provide assistance to sponsors and MAH through our established company in Ireland.


Help from DLRC Ltd

As there is no precedent for a Member State to leave the EU, it is not possible to predict with accuracy what will be the final outcome of Brexit. DLRC Ltd is actively monitoring the developments and is available to answer any questions you may have and to help you with your regulatory projects.


[1]https://www.gov.uk/government/news/medicines-and-healthcare-products-regulatory-agency-statement-on-the-outcome-of-the-eu-referendum

[2]http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/07/news_detail_002566.jsp&mid=WC0b01ac058004d5c1

[3] http://www.fiercepharma.com/pharma/will-brexit-mean-a-controversial-exit-for-drug-regulation-too-minister-won-t-rule-it-out

[4] http://ec.europa.eu/health/human-use/clinical-trials/regulation/index_en.htm

[5]http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000629.jsp&mid=WC0b01ac05808768df

[6] http://www.fiercepharma.com/pharma/will-brexit-mean-a-controversial-exit-for-drug-regulation-too-minister-won-t-rule-it-out

Starting at DLRC - Katherine's story


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A few weeks ago, Katherine, a new starter at DLRC, wrote about her experiences since joining the company. Now MD Dianne Lee reports on Katherine’s technical progress in her role and the kind of training and project work she has experienced in the last few months.

"In the short time that Katherine has been at DLRC she has become proficient in publishing, one of the first tasks in which she was involved, getting some excellent hands-on training from our eCTD publishing guru, Tim. She completed the TOPRA basics course online in her second week and has recently attended the TOPRA Cred course in variations. As part of her training, we’ve assigned Katherine to a range of projects, including assisting Michelle (Reg Proj Mngr) with clinical trials activities and supporting Laura (Snr Reg Exec), Carl (Reg Proj Mngr) and Kevin (Director) with transfer of ownership and variations submissions. Katherine was also part of a DLRC team that pitched for a significant project with an existing client as she came to us with already excellent presentation skills and featured in the proposal. We look forward to watching her develop in the same way we have seen excellent progress of our other colleagues that joined as new graduates." Dianne Lee, MD.



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As the newest member of DLRC I wanted to share my experiences of joining the company.

I started at DLRC in February 2016 with no previous experience in regulatory affairs and little idea of what to expect. I have a degree from Nottingham University in Animal Science and for the last 6 years I had worked as a zoo keeper, so this was a huge career change for me in many respects.

Starting in February I was immediately grateful for being inside in the warm and dry. For me this job was very much a coming home in both the sense of returning to my biological roots from university and a return to the county I grew up in.


I am fortunate that DLRC don’t just look at experience, but also select their graduates on the type of people they want to have in the office. Luckily my brand of cheerful optimism fell into the right category and after a series of interviews I was offered a position.


On my first day I was familiarised with the computer system, taught how to create hyperlinks and set off on my first task. I started at a busy time for DLRC and was able to aid with projects and feel productive very quickly. There is a wealth of knowledge within the office, so if I am ever unsure there is always someone who is willing and able to help me. As DLRC has previously taken on new graduates, I am surrounded by people who understand my situation, and they have all been very patient and understanding with me as I learn the ropes. Within my first week I had completed the TOPRA ‘Online Basics of European Regulatory Affairs’ course and was beginning to get involved in a wide variety projects.


Flexible hours were a new concept to me, having worked to a strict timetable previously. It allows employees to start and finish at times that suit them, as long as they are still completing their required weekly hours. There is also an option to work from home, provided your current projects are of a nature that allows for it. This amount of flexibility in the work hours means I can fit my job around my lifestyle, even when my routine changes.


DLRC is a small to medium sized company which provides for a varied workload and opportunities to obtain experience in many different areas of regulatory affairs. There is also the opportunity to be involved in the development of business processes and procedures. I am currently participating in the development of the on-boarding procedures for new members of staff, since I have the most recent experience.

With the aid of multiple abbreviation guides, a lot of support and frequent checking of the EMA website, I am slowly getting to grips with the role of a Regulatory Executive. It is early days but I am thoroughly enjoying working at DLRC. The wide range of work makes DLRC a good place to discover the many areas of Regulatory Affairs within the pharmaceutical industry.


If you too are interested in a career that offers varied opportunities and flexible working options then call 01462 372 472 or go to Join Us and send in a CV.

Launch of PRIME and EMA review

UPDATE 2nd June 2016: We are very pleased to announce that a PRIME eligibility application, submitted on behalf of one of our clients as part of the first batch of applications, is one of only 4 which have been successful. All other 14 applications submitted were unsuccessful. We are excited to see how the scheme will impact the accelerated assessment of the Marketing Authorisation Application and we keenly await the proactive support of the EMA.


We have also recently submitted a second PRIME eligibility application for a different client, to meet the third submission date of the PRIME scheme and look forward to hearing the outcome of this submission in July 2016.



From News - April 2016

On the 7th March 2016, EMA formally launched their much anticipated PRIME scheme. DLRC have already submitted an application on behalf of a client for the eligibility to the PRIME scheme - our application was completed in time for the first submission deadline of this exciting new scheme.


To ensure we were up to the minute on the PRIME scheme and other EMA activities, a number of DLRC staff attended a Review of 2015 at the EMA offices in London. Below we provide a summary of the sessions that focused on PRIME and other ways of optimising regulatory strategy by using accelerated regulatory pathways:


Jordi Llinares from EMA gave a presentation which provided a summary of the PRIME initiative. This initiative aims to enable accelerated assessment for products with a high unmet medical need in the EU. PRIME will use the existing EU regulatory framework and will encourage prospective planning, earlier interactions with stakeholders and the generation of robust data.


Eligibility for the PRIME scheme must be based on data that demonstrate a potential major public health interest. Entry to the scheme for SMEs could be as early in development as proof of principle during the non-clinical stage. For larger companies, entry to the scheme is envisaged at proof of concept or prior to phase III studies. The rationale for the different entry points is that one key aim of PRIME is to help SMEs in the very early stages of product development, where products may be lost due to lack of funding or lack of understanding of the development process and requirements.


Key benefits of the PRIME scheme were explained and included: early identification of eligibility and stakeholder involvement, rapporteur appointment at proof of concept stage, kick-off meeting with the rapporteur and relevant committees, scientific advice at key development milestones, collaboration with national incentive schemes and fee incentives for SMEs on Scientific Advice requests.


The PRIME scheme was greeted with much enthusiasm from the delegates with numerous questions for example around the stage of entry, the restriction to NMEs and the eligibility criteria.


Olga Solomon from the European Commission gave a presentation which provided information about the commission group of experts known as STAMP (Safe and Timely Access to Medicines for Patients). In March 2014, the Adaptive Pathways initiative landed and questions were raised around whether the existing legislation would be fit for purpose. STAMP was created to address these questions and to further improve safe and timely access to medicines for patients. In 2015, STAMP had discussed experiences from national early patient access schemes and the optimisation of three existing tools: conditional marketing authorisations, accelerated assessment including PRIME and the Adaptive Pathways pilot project.


Overall, a holistic approach utilising all of the currently available regulatory tools to support and facilitate early access for patients was advocated and was well received by the delegates.


If you would like more information about any of the areas covered above or would like assistance with a PRIME eligibility application, please contact our trusted and resourceful team: Email DLRC or call 01462 372 472

Launch of PRIME and EMA review 2015

UPDATE 2nd June 2016: We are very pleased to announce that a PRIME eligibility application, submitted on behalf of one of our clients as part of the first batch of applications, is one of only 4 which have been successful. All other 14 applications submitted were unsuccessful. We are excited to see how the scheme will impact the accelerated assessment of the Marketing Authorisation Application and we keenly await the proactive support of the EMA.


We have also recently submitted a second PRIME eligibility application for a different client, to meet the third submission date of the PRIME scheme and look forward to hearing the outcome of this submission in July 2016.



From News - April 2016

On the 7th March 2016, EMA formally launched their much anticipated PRIME scheme. DLRC have already submitted an application on behalf of a client for the eligibility to the PRIME scheme - our application was completed in time for the first submission deadline of this exciting new scheme.


To ensure we were up to the minute on the PRIME scheme and other EMA activities, a number of DLRC staff attended a Review of 2015 at the EMA offices in London. Below we provide a summary of the sessions that focused on PRIME and other ways of optimising regulatory strategy by using accelerated regulatory pathways:


Jordi Llinares from EMA gave a presentation which provided a summary of the PRIME initiative. This initiative aims to enable accelerated assessment for products with a high unmet medical need in the EU. PRIME will use the existing EU regulatory framework and will encourage prospective planning, earlier interactions with stakeholders and the generation of robust data.


Eligibility for the PRIME scheme must be based on data that demonstrate a potential major public health interest. Entry to the scheme for SMEs could be as early in development as proof of principle during the non-clinical stage. For larger companies, entry to the scheme is envisaged at proof of concept or prior to phase III studies. The rationale for the different entry points is that one key aim of PRIME is to help SMEs in the very early stages of product development, where products may be lost due to lack of funding or lack of understanding of the development process and requirements.


Key benefits of the PRIME scheme were explained and included: early identification of eligibility and stakeholder involvement, rapporteur appointment at proof of concept stage, kick-off meeting with the rapporteur and relevant committees, scientific advice at key development milestones, collaboration with national incentive schemes and fee incentives for SMEs on Scientific Advice requests.


The PRIME scheme was greeted with much enthusiasm from the delegates with numerous questions for example around the stage of entry, the restriction to NMEs and the eligibility criteria.


Olga Solomon from the European Commission gave a presentation which provided information about the commission group of experts known as STAMP (Safe and Timely Access to Medicines for Patients). In March 2014, the Adaptive Pathways initiative landed and questions were raised around whether the existing legislation would be fit for purpose. STAMP was created to address these questions and to further improve safe and timely access to medicines for patients. In 2015, STAMP had discussed experiences from national early patient access schemes and the optimisation of three existing tools: conditional marketing authorisations, accelerated assessment including PRIME and the Adaptive Pathways pilot project.


Overall, a holistic approach utilising all of the currently available regulatory tools to support and facilitate early access for patients was advocated and was well received by the delegates.


If you would like more information about any of the areas covered above or would like assistance with a PRIME eligibility application, please contact our trusted and resourceful team: Email DLRC or call 01462 372 472

Launch of PRIME and EMA review 2015

UPDATE 2nd June 2016: We are very pleased to announce that a PRIME eligibility application, submitted on behalf of one of our clients as part of the first batch of applications, is one of only 4 which have been successful. All other 14 applications submitted were unsuccessful. We are excited to see how the scheme will impact the accelerated assessment of the Marketing Authorisation Application and we keenly await the proactive support of the EMA.


We have also recently submitted a second PRIME eligibility application for a different client, to meet the third submission date of the PRIME scheme and look forward to hearing the outcome of this submission in July 2016.



From News - April 2016

On the 7th March 2016, EMA formally launched their much anticipated PRIME scheme. DLRC have already submitted an application on behalf of a client for the eligibility to the PRIME scheme - our application was completed in time for the first submission deadline of this exciting new scheme.


To ensure we were up to the minute on the PRIME scheme and other EMA activities, a number of DLRC staff attended a Review of 2015 at the EMA offices in London. Below we provide a summary of the sessions that focused on PRIME and other ways of optimising regulatory strategy by using accelerated regulatory pathways:


Jordi Llinares from EMA gave a presentation which provided a summary of the PRIME initiative. This initiative aims to enable accelerated assessment for products with a high unmet medical need in the EU. PRIME will use the existing EU regulatory framework and will encourage prospective planning, earlier interactions with stakeholders and the generation of robust data.


Eligibility for the PRIME scheme must be based on data that demonstrate a potential major public health interest. Entry to the scheme for SMEs could be as early in development as proof of principle during the non-clinical stage. For larger companies, entry to the scheme is envisaged at proof of concept or prior to phase III studies. The rationale for the different entry points is that one key aim of PRIME is to help SMEs in the very early stages of product development, where products may be lost due to lack of funding or lack of understanding of the development process and requirements.


Key benefits of the PRIME scheme were explained and included: early identification of eligibility and stakeholder involvement, rapporteur appointment at proof of concept stage, kick-off meeting with the rapporteur and relevant committees, scientific advice at key development milestones, collaboration with national incentive schemes and fee incentives for SMEs on Scientific Advice requests.


The PRIME scheme was greeted with much enthusiasm from the delegates with numerous questions for example around the stage of entry, the restriction to NMEs and the eligibility criteria.


Olga Solomon from the European Commission gave a presentation which provided information about the commission group of experts known as STAMP (Safe and Timely Access to Medicines for Patients). In March 2014, the Adaptive Pathways initiative landed and questions were raised around whether the existing legislation would be fit for purpose. STAMP was created to address these questions and to further improve safe and timely access to medicines for patients. In 2015, STAMP had discussed experiences from national early patient access schemes and the optimisation of three existing tools: conditional marketing authorisations, accelerated assessment including PRIME and the Adaptive Pathways pilot project.


Overall, a holistic approach utilising all of the currently available regulatory tools to support and facilitate early access for patients was advocated and was well received by the delegates.


If you would like more information about any of the areas covered above or would like assistance with a PRIME eligibility application, please contact our trusted and resourceful team: Email DLRC or call 01462 372 472

Annual European Medicines Agency Review of the Year and Outlook for 2016

The Annual European Medicines Agency Review of the Year and Outlook for 2016 took place at the EMA on 26th and 27th November. This was the 10th annual review of the activities of the EMA and the respective EU national agencies. There were eight Sessions in total across the 2 days; the full meeting report is available in the March edition of Regulatory Rapporteur. DLRC were well represented at this key conference and contributed to the writing up of 4 of the 8 sessions.


Topics covered all aspects of the regulatory spectrum from accelerated regulatory pathways (including the recently launched PRIME initiative), the forthcoming Clinical Trial Regulation to a review of EMA’s evaluations during 2015 and post-approval activities. Aspects covered are listed out below. If you would like more information on the meeting itself or specific regulatory advice for your project, please contact our trusted and resourceful team on info@dlrc.co.uk or 01462 372 472.


Session 1: Developing new medicines: What is the regulatory role in fostering and supporting pharmaceutical innovation? [written-up by Kevin Judges]


Session 2: Optimising your regulatory strategy by using accelerated regulatory pathways [written-up by Roz Sutton]


Session 3: Data sharing and disclosure – Operational aspects of EMA policies


Session 4: Regulator roundtable


Session 5: Involvement of HCPs and patients in the work of the EMA and its committees


Session 6: Reflections on 2015 – Review of evaluation highlights, surveys and progress in the area of telematics


Session 7: Post-approval activities [written-up by Fiona Bright]


Session 8: The new EU Clinical Trial Regulation [written-up by Dianne Lee]

The New Clinical Trial Regulation: What Should We Expect?

The new Clinical Trial Regulation (EU No 536/2014) aims to streamline, simplify and harmonise clinical trials in the EU, and will replace the existing Directive 2001/20/ EC. The regulation is now anticipated to come into force during Q4 2017, following full functionality validation of a new EU Database infrastructure and single online EU Portal.

The regulation will introduce a number of key provisions, including:

  • A Single Application Process: streamlined and submitted via a single entry point (the EU portal) and inclusion of the ethics committees in the assessment procedure
  • Strictly defined deadlines for the assessment of the clinical trial application
  • Reporting by the Sponsor on to the EU Portal of key trial milestones, within specific timelines
  • Increased efficiency in extending the clinical trial to another EU Country
  • A Risk-Adapted Approach, with the introduction of a category of "low-intervention trials"
  • Changes to protection of subjects in clinical trials, intended to harmonize requirements and also allow for national rules in some cases
  • Increased transparency concerning clinical trials and their outcomes
  • Data privacy changes
  • Simplified Safety Reporting requirements
  • Clearer duration of Trial Master File archiving (25 years)

While in principle the new Regulation should make it easier for pharma companies to conduct multinational clinical trials and prevent potentially numerous rounds of questions during assessment from different countries, questions remain on how the processes of the Regulation will work in practice.

Our team here at DLRC have significant experience in all aspects of clinical trial applications. If you would like more information on the new Clinical Trial Regulation, advice regarding your clinical development or assistance with Clinical Trial Applications, please contact our trusted and resourceful team on info@dlrc.co.uk or 01462 372 472.

EMA Regulatory Tools for Early Access to Medicines

Priority Medicines (PRIME)

The EMA expects to launch a new Priority Medicines scheme called PRIME in the first quarter of 2016 which aims to:

  • enable accelerated assessment for products with a high unmet medical need through earlier interactions with stakeholders and the generation of robust data
  • optimise the use of the existing regulatory framework and to encourage more prospective planning and early interaction with EMA for these important medicines

Currently, confirmation that an application will be reviewed according to an accelerated timetable is only possible just prior to filing. Under the PRIME initiative, NMEs fulfilling the accelerated review criteria can be identified much earlier in development and once identified, enhanced regulatory support will be on offer.

Key benefits of the PRIME scheme include:

  • early identification of eligibility and stakeholder involvement
  • rapporteur appointment at proof of concept stage
  • kick off meeting with the rapporteur and experts from relevant committees
  • scientific advice at key development milestones
  • fee incentives for SMEs on Scientific Advice requests

In addition to the PRIME scheme, the EMA issued two draft revised guidelines for consultation:

Accelerated Assessment

Accelerated assessment offers the opportunity for a more rapid assessment of marketing authorisation applications for medicines of major interest from the point of view of public health. The time to CHMP decision is reduced from 210 days to 150 days for standard assessments. The revised guideline aims to encourage earlier dialogue between all stakeholders so that the compressed timelines can be met.

Conditional Approval

Conditional approval allows the approval of a medicine based upon less complete data for products that target unmet medical need and target a seriously debilitating and life threatening disease. The EMA particularly noted in discussions that there is a lack of stakeholder confidence in this tool and that it is seen as a rescue solution during review of the marketing authorisation application. The revised guideline aims to increase stakeholder confidence, in particular by encouraging early dialogue and planning of conditional authorisations.

The end of the consultation period for the draft revised guidelines was 30th September 2015.

If you would like more information or advice around maximising the benefits of these early access to medicines tools in your development programme, please contact our trusted and resourceful team on info@dlrc.co.uk or 01462 372 472.