EU Clinical Trials Regulation: Anticipating the Changes
Sini Eskola, MPharm, MSc
- Director Regulatory Affairs
- European Federation of Pharmaceutical Industries and Associations (EFPIA), Belgium
Sini is working as Regulatory, Drug Development and Manufacturing Director at EFPIA since 2014 and leads the team since 2018. She is responsible for various regulatory policy and advocacy activities in relation to regulatory science and regulatory strategy. She has previously worked over 5 years at AZ R&D Global Regulatory Affairs in Sweden and 3 years as Executive Director of Finnish Pharmacists' Society. She is currently doing a part-time PhD for professionals programme at the University of Utrecht and WHO collaboration centre for pharmaceutical policy and regulation. She is a Board member of Industrial Pharmacy Section in International Federation for Pharmacists and Pharmaceutical Sciences since 2010.
John Poland, PhD
- Regulatory Affairs Consultant
- Association of Clinical Research Organizations (ACRO), United Kingdom
John has worked in Regulatory Affairs since 1979 until retiring from Covance, where he had global responsibility for regulatory policy and compliance, in March 2015. John is a former chair of the ACRO European Scientific and Regulatory Committee and now acts as a consultant to ACRO.
- Development Excellence Leader, Pharma Portfolio Management
- F. Hoffmann-La Roche Ltd, Switzerland
Development Excellence Leader (Roche), based in the UK. Specialist in Organisational Change and Development. Trained coach, certified learning and development specialist (CIPD) and practitioner in Change Management (PROSCI).
- F. Hoffmann-La Roche AG, Switzerland
Claire Berry is a Group Manager in Clinical Trial Regulatory Management at F. Hoffmann-La Roche Ltd. based in Basel, Switzerland. She has been working in Regulatory Affairs for over 12 years and has been involved in the development of a number of drugs from early to late stage across several Therapeutic Areas. Before joining Roche she worked for 3 years in Solvay Pharmaceuticals GmbH (now Abbott). Claire received a Doctor of Veterinary Medicine and has a Master's Degree in Business Administration.