Jean-Marie Vlassembrouck has over 30 years of experience in healthcare first in the pharmaceutical industry, then in the medical devices, biological and biotech industry.
He established and held the European regulatory and industry affairs position for 3 M healthcare in Europe for 8 years. He then joined Baxter for 20 years, being responsible successively for Industry and Governmental Affairs in Europe, Public Affairs in Europe and finally appointed as Vice-President of Industry affairs worldwide for the Bioscience division.
He was involved with Eucomed, now Medtech Europe for a long time, being the Chairman of the association for 5 years. He also acted as Chairman of the Global Management Committee of the Plasma Protein Therapeutic Association for 11 years. Jean-Marie is still active today through his consultancy company providing strategic support on market access issues.
Ariela Bardach has 30 years of experience in the organizational development field. She started her career as an organizational consultant in one of the leading consultancy firms in Israel, serving various organizations, governmental ministries, municipalities and the Israeli army. She later led the HR department of a holding company in the high-tech industry.
For the last 10 years, she has designed, through her consultancy company, growth platforms for employees and organizations, laying the infrastructure for both individual self-fulfillment and organizational aggregated development. She also does executive mentoring and develops leadership programs.
She is a strong advocate for non- linear, agile thinking, for the strong bond between individual progress and collective organizational progress. Her passion is empowering people to develop their potentials to the fullest, to bring value to their working place and to their personal life. Her professional interests focus on finding the next advantage, paradigm shifting and behavior change. She also serves as a member of the Obelis Advisory Board. She received her M.Sc. in management science from Tel Aviv University.
Dario Pirovano has over 30 years of experience in Medical Technology, as designer and regulatory affairs expert. He worked for 7 years as R&D and regulatory manager with Ohmeda in Milan signing some 20 projects for anesthesia machines, lung ventilators and neonatal care devices.
He worked for 4 years within the Commission of European Communities where he contributed to drafting and negotiating the 90/385 /EEC and 93/42/EEC directives. He was then director of Medical Technology Consultants Europe from 1991 to 1995. In 1995 he founded Pirovano Management SPRL, a consulting firm advising manufacturers, Notified Bodies and authorities in regulatory matters related to Medical Technology. Dario can be considered the historical memory of the development of medical devices regulation in Europe.
Dario holds a Doctorate in Engineering from the Politecnico di Milano. Italian being his mother tongue, Dario is also fluent in English and French with basic knowledge of German and Spanish. Since 2002 Dario is Senior Regulatory Affairs Adviser for Eucomed on a consulting basis.
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).
Dr. Janette Benaddi
Janette Benaddi is a business mentor, international speaker, author and consultant to the life science industry. Janette has over 20 years’ experience in the field of medical devices including regulatory and clinical affairs. In 1998 she setup and grew a very successful medical device consultancy, which she later sold in 2013.
Janette has worked with several multinational organizations in various clinical, regulatory and marketing roles during her career in the industry.
She has extensive experience of conducting clinical studies with medical device products as well as regulatory expertise for CE marking of devices.
Janette qualified as a registered nurse in 1984, she has a BSc in Management studies, a Diploma in Company Direction, and a Diploma in Management studies, she holds a teaching certificate
and is a Chartered Scientist and Chartered Director. She also has an honorary doctorate in health sciences. Janette is a seasoned non-executive Director and sits on the board of several medical device and other industry companies.