Dr. Bassil Akra
Dr. Bassil Akra is the vice president of the global strategic business development at the medical health service of TÜV SÜD Product Service. Dr. Akra has long experience in research, development, quality management and regulatory approval of medical devices, combination devices and ATMP products.
Dr. Akra was leading multiple conformity assessment projects of medical devices incorporating an ancillary medicinal substance and has experience with different competent authorities designated by the Member States or the EMA. He is presenting worldwide the requirements in Europe and is involved in the development of several European guidance documents and standards.
Dr. Akra is member of the European Clinical Investigation and Evaluation working group and is representing Team NB and NB MED in several European discussions regarding the clinical and post-market requirements. Dr. Akra is member of the German MDR Implementation Working Group, the NAKI. He is also an active member, representing NB MED in the various MDR European task forces such as the one on PSUR, SSCP and new clinical data requirements.
Erik specialises in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software and protection of personal data. He is an expert in life sciences regulation at EU and Dutch level, with a focus on contracts, regulatory litigation against competent authorities and M&A. Erik was initially trained as intellectual property and competition lawyer, starting his career at the Directorate-General for Competition of the European Commission. He subsequently gained experience in contentious matters, commercial contracts, and transactional work at three large international law firms.
He actively contributes to law and policy development at national and EU level via membership of specialized committees at branch associations and the European Commission. Erik also works as arbitrator in medical devices related disputes and is regularly retained as expert witness in foreign litigation.
Erik’s blog can be found at Medical Devices Legal.
John L. Webster
Mr. Webster has over 40 years of quality assurance, regulatory and management experience and served for many years as European Director of Regulatory Affairs for Boston Scientific based in Paris and previously for Meadox Medicals Inc. in UK.
Most recently, he was Principal Consultant and Managing Director of the European office of US based organisation providing medical device consulting and European Authorised Representative services. Since 2010, Mr. Webster has served as Senior Regulatory Consultant for the Obelis Group based in Brussels and providing EU Consultancy Services and Authorised Representative Services for the Medical Device and other Directives.
During the writing of the Medical Device Directive, he was responsible for technical affairs at EUCOMED representing the medical technology industry in Europe, and chaired the committee writing the Essential Requirements in Annex I of the Directive. Mr. Webster has chaired the committee responsible for writing the European standards on labelling and symbols used with medical devices (CEN/CLC/TC 3/WG 1) since its creation.
He regularly speaks at professional conferences on all aspects of medical device quality and regulatory compliance. He holds a higher degree in Chemistry from the University of Newcastle upon Tyne, is a Chartered Chemist and a member of the Royal Society of Chemistry (C.Chem, M.R.S.C.), holds a Diploma in Management Studies from the University of East Anglia, is Certified as a Quality Engineer by the American Society of Quality, is a Fellow of the Regulatory Affairs Professional Society (RAPS), serves on the European Operating Committee and is Regulatory Affairs Certified (RAC).
Mika Reinikainen is a founder and Chairman of the European Association of Authorised Representatives (EAAR).
He is the founder of Abnovo Ltd, a medical device consulting company. Previously, he served in the position of Vice President at Quintiles. His company focuses on regulatory strategy and compliance, as well as resolving manufacturers’ conflicts with Notifies Bodies and Competent Authorities. He also provides regulatory interpretation and advocacy, in particular on borderline determination between legal regimes.
Mr. Reinikainen has more than 30 years of experience in the European medical device field: as regulatory affairs manager in industry (Pfizer Hospital Product Group of companies), as healthcare legal counsel (Hogan & Hartson) and as as a regulatory consultant (Medical Technology Consultants Europe, BRI and Quintiles).
He was directly involved in the development of the Medical Devices Directives (chairing the working group that developed the European medical device classification system and later as a consultant to the European Commission on classification) as well as through various roles in trade associations. He also served as the former Chairman of CEN TC 257 (technical standards).
Mr. Reinikainen is currently a member of the European Commission’s Medical Device Expert Group and of the Commission’s Working Groups on Borderlines and Classification, Software and New & Emerging Technologies. He is a former Vice President, Europe, of the Regulatory Affairs Professionals Society (RAPS).
He holds a Master’s degree in law from the University of Nice (France) and a Master’s degree in Business Administration from Wharton (University of Pennsylvania, USA).
Roland Gerard is a regulatory affairs expert with 30 years of experience in the field of high risk implantable medical devices.
Roland has worked for the European Committee for Standardization (CEN), Intermedics and more recently for St. Jude Medical where he occupied the position of Vice President RA/QA in the International Division.
During all those years, he has developed an in-depth knowledge of EU Medical Device Directives and Environment Legislation as well as standards and quality management system (ISO 13485) implementation and certification, has extensive experience in CE marking and in dealing with competent Authorities and Notified Bodies, has experience in working with senior management to support business needs, speed up market access and manage crises.
Mr. Gerard has been a member of GHTF study group 2, GHTF Steering Committee, President of RAPS Europe, President of IAPM, Chair of the Regulatory Affairs Committee of IAPM and more recently Chair of the Regulatory Affairs Committee of EUCOMED. He has been involved in numerous conferences as a speaker as well as in the development of the new Medical Devices Regulation.