Ajda Mihelčič joined Obelis Regulatory department in 2017 to assist clients through the EU compliance process. She is Manager of the Publications department since 2019, supervising all regulatory content externally published, and ensuring timely circulation of regulatory developments.
Ajda holds a law degree from the University of Ljubljana and an Advanced Master’s degree from Saint-Louis University of Brussels. She has been gathering experiences at the European institutions, in the international judiciary and in the non-governmental branch. Regulatory affairs, namely medical device sector, were her main focus in the past years, while managing the Information Platforms MDlaw.eu and COSlaw.eu.
Ajda is native Slovenian with fluency in English and French, and is improving her Italian. She is passionate about EU law, knowledge sharing and firmly believes in the European project.
Pablo De Mingo Monge
Pablo de Mingo Monge is a Junior Consultant in the Publications department at Obelis Group.
Pablo holds a Bachelor degree in Political and Public Administration Sciences from the University of Valencia and a Master’s degree in European Studies and International Relations from Maastricht University. He has practical experience in policy analysis and implementation, regulatory research and legal text analysis.
Pablo is native Spanish with fluency in English and a good knowledge of French. He is passionate about communication and public affairs, as well as international relations and geopolitics.
Anna Karavasili is a Junior Consultant in the Regulatory Affairs department at Obelis Group.
Anna holds a law degree from Democritus University of Thrace and a LLM in Public International Law from Leiden University. She has working experience in a law office in Greece.
Anna is native Greek with fluency in English and a good knowledge of German. She is passionate about international law and politics.
Simona Varrella is an Expert Consultant in the Publications Department at Obelis Group.
Simona holds a bachelor degree in linguistics and a master in multilingual educational linguistics. In her university career, she studied at the University of Naples L’Orientale, University of Heidelberg, University of Vaasa, and University of Hamburg.
She has experience in editing, translation, and editorial research in four different EU countries and cultivates a vivid interest in communications, European Law, and politics. Simona is fluent in English, German, and Italian and is improving her French and Spanish.
Dr. Bassil Akra
Dr. Bassil Akra is CEO and Owner of AKRA TEAM GmbH, a consultancy company which was founded to support the various stakeholders in the healthcare system achieving their target in a highly regulated business area. He spent many years as a subject matter expert at the biggest notified body in Europe acting in the various roles and representing locally and globally the notified body association in the various European discussion and guidance documents preparation.
Dr. Akra was the Vice President of strategic business development at the Global Medical Health Services of TÜV SÜD Product Service GmbH. He has long experience in leadership, business management, research, development, quality management and regulatory approval of medical devices, combination devices and ATMP products.
Dr. Akra played an essential role during the implementation of the medical device regulation (MDR 2017/745) in Europe and was involved in the drafting of the several European guidance documents (e.g. MEDDEV, MDCG, etc.). He was also actively engaged in the application and finalization of the designation and notification process of TÜV SÜD Product Service GmbH for both the MDR and IVDR.
He spent the last years of his career at TÜV SÜD training and educating the various stakeholders on the EU Legislations (e.g. MDD/AIMDD, MDR and IVDR) and their impact on the EU healthcare system.
Eric A. Klasen
Life Sciences expert in Regulatory Affairs and Quality Assurance systems with focus on solutions underpinning Healthcare strategies and Business objectives.
Member of the Board of Directors and Treasurer of the European Forum of Good Clinical Practice, Belgium. Member of the Board of Directors of SimpliNext, Switzerland. Member of the Supervisory Board of DIABETER, a group of Diabetes clinics in the Netherlands, and chair of the Supervisory Board of NOK/Best Care Foundation, a group of Obesity Clinics in the Netherlands.
From July 2004 – May 2019, he was Vice President EMEA Regulatory Affairs & Quality at Medtronic International Trading, Switzerland, and founder and President of Medtronic BioPharma Europe. He retired from Medtronic in May 2019.
Prior to Medtronic, he held the following positions:
1998-2004, Head of Global Drug Regulatory Affairs at Novartis Consumer Health, Switzerland (currently GSK Consumer Healthcare).
1994-1998, Director Regulatory Compliance, Quality Assurance and Quality Control at Chiron Vaccines (currently GSK Vaccines), Italy.
1986-1994, Director R&D at Serono Diagnostics, Italy, Director Operations Technical Support at IFS (Istituto Farmacologico Serono), Italy, and Director of QA/QC at Serono Biotech, Switzerland (currently Merck–Serono).
1982-1986, Head of the Immunochemistry Department at TNO Medical Biological Laboratory, Netherlands.
1977-1982, Researcher at the Dept of Human Genetics of the University of Leiden, Netherlands.
He obtained a BSc. degree (1975) in Biochemistry and an MSc. degree (1977) in Biochemistry & Genetics from the University of Leiden, Netherlands.
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.
Dr. Louise Olliver
Louise Olliver has more than 30 years’ experience in regulatory affairs and quality management in the fields of medical devices, in vitro diagnostics and pharmaceuticals. Her qualifications include a PhD in Molecular Biology, an M.Sc. (Chemical Pathology) and BSc (Med) (Hons) Biochemistry and Microbiology.
Her consultancy business was established in 1989 and has been engaged by a broad range of clients from small-scale start-up companies, consultancies, to blue-chip corporations. As a member of the EU Technical Committee TC 210 Quality Management Systems and Risk Analysis for Medical Devices she contributes to reviews and revisions of EN ISO 13485 and EN ISO 14971. Louise has partnered on H2020 consortia, speaks at professional conferences and delivers bespoke in-house training.
A special thanks to previous MDlaw contributors:
Giorgia de Stefano
Giorgia de Stefano joined Obelis from 2021 to 2022. She started her journey in the Regulatory Affairs Department, where she helped manufacturers to comply with EU, UK and Swiss regulatory requirements to successfully place their products on the different markets. She then joined the VIP & Legal Department, to ensure regulatory compliance within tight deadlines for VIP clients and assist the company with legal activities.
MDlaw Team would like to thank Giorgia de Stefano for her contributions to the platform!