Supporting regulatory professionals conveying complex healthcare messages to a broader audience.
WINNER: Anja Holm – formerly Chair of the Committee For Medicinal Products For Veterinary Use (CVMP), Denmark
Anja chaired the CVMP at the European Medicines Agency from June 2010 to June 2016. During that period she demonstrated excellent communication skills to colleagues from EU regulatory agencies and industry. Anja was responsible for planning and leading the monthly meetings of the CVMP, taking robust scientific decisions by consensus or voting, leading the strategic progress in the projects and representing the Committee in meetings.
Leslie Dowling – Director, Apex Reg Ltd, UK
Leslie is now the longest-serving Editor-in-Chief of the journal ‘Regulatory Rapporteur’ – with five years in this voluntary role and three years as Deputy Editor. She leads a 30-strong team of consultant editors and office support staff. Under Leslie’s leadership the journal has become increasingly well-respected by agencies and industry alike – and it is seen as an essential read among regulatory professionals.
Stephen Lee – Biosciences Team Manager, MHRA, UK
Steve is the Biosciences Team Manager in the Devices Division of MHRA. He is a Chartered Scientist with 20 years of experience in biomedical sciences and the regulation of in vitro diagnostic medical devices. He chairs the European Commission's IVD Working Group and is a strong supporter of good communication being vital to ensure that Biosciences advance in both the UK and Europe, along with the application of appropriate but pragmatic and proportionate regulation.
Recognising experienced individual RA professionals who do an excellent job
WINNER: Eva Kopecna – Head of Global OTC Regulatory Affairs, Teva, Switzerland
Eva’s contribution at both national and international levels spans education, communication and strategy. Eva successfully set up the Global OTC organisation for PGT Healthcare. As Head of Global OTC Regulatory Affairs at TEVA she has built, trained and mentored a team of over 100 regulatory affairs professionals managing product registrations in over 100 countries. In addition, Eva is the author of several publications on GCP and clinical trials. Eva makes a major contribution to the TOPRA MSc and lectures in a variety of settings for Pharmaceutical Universities in the Czech Republic and Singapore.
Anastasia Samochernova – Head of Regulatory Affairs for Russia/CIS, RB, Russia
Anastasia is currently the Head of Regulatory Affairs for RB Russia and CIS markets where she leads complex registrations, supports clinical studies, drives compliance at the forefront of a highly complex regulatory environment. She has trained and motivated a strong team of regulatory professionals. Externally, she represents the company at national and international trade association meetings, acting as a strong advocate, championing and raising the profile of regulatory science.
Emma Hughes – Senior Manager Regulatory Governance, Global Regulatory Compliance & Maintenance, RB, UK
Emma has led a successful regulatory career through her leadership of SSL International’s Regulatory department, championing the RB/SSL integration and leading the ‘wellness’ regulatory team in innovation and compliance activities. She is now responsible for compliance, continual improvement and regulatory intelligence and systems which underpin the management of products, issues and changes internally and externally.
Marie Deneux – Senior Director, Regulatory Science, Drugs and Biologics, Voisin Consulting Life Sciences, Cambridge, MA, US
Marie Deneux has proved that regulation must be at the heart of effective therapeutic strategies from the outset for innovations to be successful.
GMPO, a biotech company developing and registering innovative medicines from repositioned molecules in rare diseases with high medical need, worked with a regulatory team led by Marie on two drug candidates to achieve a consistent MAA dossier, three years after the kick-off of the whole development of the product in a rare metabolic disorder.
For educators and course leaders developing regulatory education.
WINNER: Roche EU Regulatory Trainee Programme – Roche, Switzerland
After the success of the Regulatory Trainee Programme at Roche Basel, a similar programme was launched in the UK to establish and support graduate training, with ongoing positive results to the company and the graduate trainees at the start of their regulatory career.
Marty Majchrowicz, Detlef Hold, Kathy Winson, Mary Honma, Lynn Ramage, Melissa Schweizer, Sylvie Billardon and Steve Slater – Roche Regulatory Affairs, US
This team developed a capability-building programme that has transformed the way Roche prepares team members to participate in global marketing filings and by doing so enhances the quality of submissions. The initiative brings together multiple functions and is continuously evolving to support filing excellence.
Susana Vázquez and Dora Isolabella – Regulatory Online Course Professors, University of Buenos Aires, Argentina
Susana Vazquez, a pharmacist with more than 35 years of experience in the pharmaceutical industry, and Dora Isolabella, a professor of Pharmacology in the University of Buenos Aires, realised how difficult it was for professionals to stay up-to-date with changing regulations. In 2011 they approached the University with the idea of offering a new postgraduate online course on regulatory affairs. Since then, they have offered this course for 6 years to over 500 students across Argentina, Venezuela, and Spain.
TRAC-The Regulatory Affairs Consultancy – UK
Based in Cornwall for 15 years, TRAC knew that robust training would be core to a recruitment strategy that could ensure business success. Of TRAC’s 17 regulatory consultants, only 2 had any previous industry experience. TRAC focusses on ensuring they do not overlook excellent candidates because they have no regulatory experience, and instead ensures that their training and education programme is exemplary.
For recent entrants into the profession who have already shown great potential.
WINNER: Emily De Lay – Senior Regulatory Associate, Pfizer, UK
Since joining Pfizer in 2015 Emily has demonstrated her commitment to performing technical regulatory activities to a high standard. She has also taken on coaching and the mentorship of other colleagues. Emily shows leadership in her rare disease regulatory projects to find the optimal solutions for patients, prescribers and Pfizer. It’s not just getting the job done, but how Emily achieves it by engaging others and working in a team.
André Sousa – Regulatory Affairs Specialist, PPD, Portugal
André is a highly motivated regulatory affairs professional with only two years’ experience, but his confidence, knowledge and proactivity give the impression of someone with many more. He has successfully taken the regulatory lead role on a portfolio of projects: at the moment he is managing 12 oncology studies!
Orlaith O Brien – Regulatory Affairs Manager, EirGen Pharma, Ireland
In 2012 Orlaith became the first employee of EirGen’s Regulatory Affairs team. Since then shehas completed the TOPRA MSc in Regulatory Affairs and progressed to leading a team of 6 staff. Within this time Orlaith has also been responsible for several EU and US licence applications and over 100 Rest of World registrations. Orlaith has successfully obtained MUMS designation for a product in both EU and US.
Sarah Jurmeister – Regulatory Affairs Specialist, PPD, UK
Sarah Jurmeister has demonstrated exemplary project work, technical expertise and focused commitment to regulatory affairs. She consistently delivers to the highest quality with minimal supervision and a level of professionalism well beyond her years. Sarah possesses the drive and natural leadership skills to pursue a successful career in this field.
Recognising the achievements of those who have significantly improved the regulatory process.
WINNER: Max Kanevsky and Pinnacle 21 LLC – US
In 2008, Pinnacle 21 created a free, open source toolkit (originally called OpenCDISC, now Pinnacle 21 Community) that revolutionized how life-sciences companies validate their data against CDISC standards. The open source toolkit was broadly adopted and embraced by the life-sciences industry.
Helen Corley – Director, Global Regulatory Affairs, Quintiles, UK
Helen’s innovation is a novel, agile Regulatory Affairs and Pharmacovigilance outsourcing model for established products registered globally, called the Marketed Products Maintenance Model. It is designed to cover hundreds of Active Pharmaceutical Ingredients and thousands of registrations. The regulatory services include Lifecycle Maintenance, Labelling and CMC and they are fully integrated into the client’s systems and procedures.
Priya Bhutani and RegDesk – US
Priya Bhutani has introduced a first-in-kind technology that helps sponsors solve complex global regulatory challenges in an innovative way. RegDesk’s approach has been shown to reduce significant risk, time, and cost for sponsors, allowing them to obtain comprehensive and accurate guidance quickly and at lower cost.
Acknowledging senior professionals who inspire and mentor others.
WINNER: Dianne Lee – Director, DLRC Ltd, UK
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 encouraged regulatory professionals to work in an individualised way, adapting the traditional working week to suit family and other external commitments.
Elizabeth Madichie – Global Head, Regulatory Affairs, PPD, UK
Liz has worked in regulatory affairs for more than 20 years and for PPD for over 10 years. As head of regulatory affairs she has positively impacted the performance and development of numerous PPD staff, which directly affects the quality of regulatory services that the company provides to clients and internal stakeholders. She has championed the regulatory function within a multifunctional and strongly matrixed organisation, creating and maintaining belief in the core values of regulatory affairs.
Martine Zimmermann – SVP Global Head of Regulatory Affairs, Alexion Pharma GmBH, Switzerland
Martine has been a role-model and inspiration for many young regulatory professionals within and outside of her organisation. She has successfully delivered winning strategies for products in orphan and ultra-orphan indications. Her inclusive leadership with direct reports, colleagues, mentoring students and trainees has been instrumental in supporting new developments.
Sofia Oliveira – Regulatory Affairs Sub-Regional Lead AT/BELUX/NL/PT, MSD, Portugal
Sofia is far more than a leader of regulatory teams in different countries. She is capable of creating regulatory solutions and implementing projects to face regulatory challenges in a visionary way. She is a wonderful leader by example and is her team’s everyday inspiration to be better.
For service providers and consultants who go the extra mile for their clients.
WINNERS: Mel Munro and Rhona Banks – Regulatory Consultants, Triveritas (and RA-Elect), UK
Dr Mel Munro & Dr Rhona Banks have assisted LETI for a number of years. Their expert knowledge of vaccine development and EU regulations has been applied with enthusiasm and good humour throughout. They have become integrated into this client team, providing strategic scientific and regulatory support on every single aspect of the project. With their pivotal help and continual training the client has built a dedicated and effective team to achieve an exceptional outcome.
Kathryn Hutchinson and team – Regulatory Affairs and Clinical Research Departments, Advanced Medical Services (AMS), UK
BioCryst Pharmaceuticals contracted with AMS for regulatory submissions and clinical management of EU sites for a Phase 2 study in an ultra-orphan indication. AMS rose above every challenge to provide high-quality data in a timeframe that could set industry records. AMS adapted to working in a new, challenging indication in few diagnosed subjects and each AMS employee personally invested in contributing to the success of the client’s project.
Regulis Consulting – UK
Regulis is the sole European regulatory service provider for Delcath, a specialty pharmaceutical and medical device company focused on oncology. In the past 18 months Regulis has managed diverse regulatory activities for them under stringent timelines. Delcath say ‘the Regulis team has provided superb regulatory oversight and input ... Their level of drug and device regulatory expertise is quite formidable and has been vital in helping us reach our goals.’
Acknowledging the role of regulatory science in bringing innovative technologies and medicines to the clinic.
WINNER: Stephen Liggett – Research Governance Manager, Queen’s University Belfast, UK
Due to his previous experience as a Regulatory Scientist, Stephen was approached by several Senior Academics within the University to support their research programmes. He initiated a unique Regulatory Advice Pilot for a period of 6 months in the Research and Enterprise Directorate. The pilot has been a success raising the profile of Regulatory Science within the University and building firm links with external organisations such as the MHRA, Cell Therapy Catapult and Industry.
Flavio Kakimoto and Gary Bowman – Regional Regulatory & Medical Affairs Director, LATAM, RB, Brazil and Global Regulatory Affairs Manager, Pest Control, RB, Australia
The RB regulatory teams led by Flavio and Gary responded swiftly to the Zika crisis to engage with the Brazilian Health authorities to promote new insect repellents and public health benefits. They faced many regulatory challenges including gaining the commitment of the Regulatory Agency to accelerated approvals in this emergency situation.
Lifetime achievement Award
The winner of the 2016 Lifetime Achievement Award was Daniel Brasseur.
Daniel is a paediatrician who has dedicated his whole career to championing improvements in the health and well-being of children.
He started his career over 30 years ago in Africa, and having seen the poor food and hygiene conditions first hand, he focused his clinical research and teaching in the areas of paediatric nutrition and immunization.
It was his work as a clinician at the University Children’s Hospital Queen Fabiola which really alerted him to the clear difficulties paediatricians face when constantly having to treat children ‘off label’ with medicines developed solely for adult use.
As a member of the Belgian Drug Commission, he was sent to the EMEA as a CPMP delegate and in 1997, became the chair of the new CHMP for six years. Highlights during his reign as CHMP chair include the progress made by the development of the scientific advice working party, the development of pharmacovigilance and risk management and the creation of the European-level conditional marketing authorization.
He continued his advocacy for paediatric medicines when he became the first chair of the newly formed paediatric committee (PDCO) at the EMA in 2007, leading the PDCO through its infancy as a newly formed committee, which on average oversaw the agreement of over 100 PIPs a year during the first 5 years of the regulation.
This early role of the PDCO was pivotal, as it brought together a high level of agency expertise and competence. The Committee contributed to the scientific guidelines published by the EMA and have so far convened approximately 30 expert workshops on the development of medicines for children.
In his six years as PDCO chair our winner showed exceptional leadership as both industry and the PDCO sought to optimally implement the new procedure. He has always had excellent interfaces with all stakeholders and has been an important contributor to meetings including those for TOPRA, DIA or ICH. This has been for him the opportunity to raise awareness on various topics related to paediatrics, especially on how to fulfil the paediatric regulation requirements for the benefit of children.
We know him as a courteous and committed colleague and thoroughly deserving of this Award.