The committee supports the key objectives of the BIA’s regulatory affairs activity and provides the opportunity for BIA members to contribute to its agenda.
The joint BIA/MHRA conferences supported by the committee have been particularly well received, bringing in globally recognised speakers to discuss and debate key regulatory policy issues for the life sciences sector.
- Bring together regulatory affairs representatives from the BIA community and use this group as a key touchpoint for engagement with key stakeholders at a UK and EU level, including MHRA, NIBSC (National Institute for Biological Standards and Control), CPRD (Clinical Practice Research Datalink), NICE and the EMA.
- Support delivery of the joint BIA/MHRA 2018 Regulatory Conference.
- Input to BIA Brexit work, including input to help shape the post-Brexit UK regulatory framework and MHRA future role as part of the UK innovation ecosystem and at a global level; and minimising disruption to patient access to medicines after the UK leaves the EU.
- Support BIA work to improve early access to innovative medicines in the UK, including input to help shape the new accelerated access pathway for breakthrough products and engagement with NICE on relevant issues, for example information sharing to support NICE reviews, in line with AAR implementation.
- Strengthen collaboration with NIBSC, e.g. scientific dialogue on innovative products and technology platforms, including advanced therapies and linking across to work of both CGTAC and MAC in taking forward regulatory actions from the Advanced Therapy Manufacturing Taskforce Action Plan.
- In addition to supporting work on key themes listed above, provide expert advice as appropriate, including providing BIA unique insights for a supportive regulatory environment for R&D and innovation, maintaining UK alignment with EU and international standards.
Committee Chair: Alan Morrison, Vice President International Regulatory Affairs, MSD
Committee Vice-Chair: Emma Du Four, Head of International Regulatory Policy and Intelligence, AbbVie
For more information contact: Dr Christiane Abouzeid, Head of Regulatory Affairs
AbbVie combines the focus and passion of a leading-edge biotech with the expertise and capabilities of a long-established pharmaceutical leader to develop and market advanced therapies that address some of the world’s most complex and serious diseases.
Amgen discovers, develops, manufactures, and delivers innovative human therapeutics. A leader in biotechnology since 1980, Amgen was one of the first companies to realise the new science’s promise by bringing safe, effective medicines from lab, to manufacturing plant, to patient.
Arnold & Porter Kaye Scholer LLP
Arnold & Porter is a leading international law firm headquartered in Washington DC with a number of other offices nation-wide in the US including in New York and with a rapidly growing presence in London.
AstraZeneca is a major contributor to UK science and innovation investment, economic prosperity and to patient health. The UK is home to the organisations global headquarters and major research and development and manufacturing facilities. AstraZeneca invest over £1.3 billion per year in research and development in the UK.
Biogen UK Ltd
Biogen Idec helped create an industry that has touched countless lives. We were among the world's first biotechnology companies, and today we are the oldest independent biotech firm in the world.
BioMarin Europe Ltd
BioMarin is a world leader in developing and commercializing innovative biopharmaceuticals for rare diseases driven by genetic causes
Celgene R&D Sarl
Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide.
Cell and Gene Therapy Catapult
The Cell and Gene Therapy Catapult was established in 2012 as an independent centre of excellence to advance the growth of the UK cell and gene therapy industry, by bridging the gap between scientific research and full-scale commercialisation.
Chugai Pharma Europe Ltd
Chugai Pharma Europe Ltd main purpose is to develop Chugai’s development candidates (from Chugai’s own research efforts or via licensing-in agreements and collaborations) from the pre-clinical stage through to Phase III, as part of an international development team.
Consistently recognised as one of the leading life sciences firms worldwide, Covington is dedicated to serving the specialised needs of our life sciences clients in the UK, Europe, the United States, Asia and other major and emerging markets.
Gilead Sciences Ltd
GSK is a global pharmaceutical company dedicated to helping people feel better, do more and live longer.
Kinesys Consulting Ltd
We aim to help you find answers to the big and the frustrating but often important small questions that arise in your regulatory and development strategies.
Today's MSD is a global healthcare leader working to help the world be well. MSD is a tradename of Merck & Co., Inc., with headquarters in Whitehouse Station, N.J., U.S.A
Pfizer Global Research & Development
Pfizer are committed to applying science and our global resources to improve health and wellbeing at every stage of life. We strive to provide access to clinically effective and affordable medicines and related healthcare services to the people who need them.
PsiOxus Therapeutics Ltd
PsiOxus Therapeutics Ltd is a private Oxford-based, UK development stage biotechnology company developing novel therapeutics in the field of cancer.
Takeda Development Centre Europe Ltd
Takeda is a research-based global pharmaceutical company. It is the largest pharmaceutical company in Japan and one of the global leaders of the industry.
Tusk Therapeutics Ltd
Tusk Therapeutics is developing novel immune modulating therapeutics based on an in-depth understanding of the innate immune system
A global biopharma focused on severe diseases with operations in more than 40 countries and global revenue of € 3.2 billion in 2010.
Vectura Group Plc
Vectura Group plc develops inhaled therapies principally for the treatment of respiratory diseases. Vectura’s main products target diseases such as asthma and chronic obstructive pulmonary disease (COPD), a growing market that is currently estimated to be worth in excess of $25 billion.
Vertex Pharmaceuticals (Europe) Ltd
Vertex creates new possibilities in medicine. Our team discovers, develops and commercializes innovative therapies so people with serious diseases can lead better lives.