Conference Speakers

 

Back to Programme

 

Session 1: Regulatory Update for Combination Products in Europe and in USA: Status, Lessons and Future Vision

 

Moderator:

Dr. Yves Th. Tillet, CEO, WHITE-TILLET Consultants & Experts

 

Yves Th. Tillet is pharmacist, graduate of physiology and biochemistry, of the Business Administration Institute, and of Marketing and Strategy from the Centre for Higher Education. Yves Th. Tillet began his professional career in the field of hospital biology and clinical pharmacy. In 1983, he was shareholder and general manager of a consulting firm specialising in "in and out" Registration and Licensing of drugs in Europe (IDD). In 1985, he created and directed a services company specialising in Clinical Trials and Biostatistics (Clinica & Statistica). During this period, he organised a number of international seminars on the development of drugs and clinical methodology in collaboration with recognised experts (Dr Bernard AVOUAC, Pr Gilles BOUVENOT). In 1994, Yves Th. Tillet and Marie D. White created the Cabinet WHITE-TILLET providing expertise and experience in the field of Consulting and Assistance in Quality, Development, Evaluation and Regulation of health products: Drugs, Biologics, Cell and Gene Therapy, Human Tissue Engineered Products (hTEPs), Natural Products, Biomaterials, Medical Devices, Drug/Device Combinations, medical-related Cosmetics and Food Supplements.

The Cabinet WHITE-TILLET also assists clients with legal, regulatory and economic affairs with competent national health administrations or registration agencies in Europe. Yves Th. Tillet is a member of the Scientific Council of the Medical Care System and provides expertise to several official organisations in France, among which are the Centre of Medical Technologies of Saint-Etienne and APPAMED. He teaches quality, development and regulation of drugs, medical devices and product combinations in Université de Cergy Pontoise and Faculté de Pharmacie de Lille. He manages the working group of medical devices and products combinations in AFAR (Association Française des Affaires Réglementaires).

Yves Th. Tillet currently assists researchers as well as pharmaceutical or biotech companies in development and regulation from raw materials to reimbursement products process.

 

 

 


 

 

Faraj Abdelnour, President of ACIDIM, Senior Consultant Europe, Quintiles Consulting

 

 

 

 


 

 

Regulatory update in France

Stephane Palies, Referent for innovation, AFSSAPS

 

Afssaps, Référent Innovation, Direction Générale depuis avril 2008. Pour plus d’information sur cette « mission » de l’agence : http://www.afssaps.fr/Activites/Accompagnement-de-l-innovation/Afssaps-et-innovation/(offset)/0

 

Expériences précédentes :
1993-2008 : Recherche clinique de Pfizer, essais cliniques de phase 1 à 4, études épidémiologiques, études médico-économiques… Attaché de Recherche Clinique, puis Coordinateur Essais Cliniques, puis Responsable de Gamme et enfin Directeur Ressources et Performances
1992-1993 : Attaché de Recherche clinique en CRO Stephane is in charge of AFSSAPS’ innovation desk since April 2008. This Afssaps’ new service tries to support health innovation by several potential ways (as Scientifics or Regulatory advices for example) with mutual benefits:
• For Afssaps: future market anticipation, new potential risks identification, regulatory gaps identification ...
• For applicants: regulatory highlighting and identification of regulatory authority’s expectation, helping to build the scientific and strategic development plan ...
• For patients: accelerated access to innovation (clinical trials, marketed product) due to better CTA or MA file which make easier Benefice / risk evaluation.

Previously he has been involved for more than 15 years in clinical research, phase I to IV, as CRA, project manager, therapeutic area manager and Head of monitoring group for one of the most successful pharmaceutical company.

 

 

 


 

 

 

Regulatory update in the UK

Elizabeth Baker, Group Manager Licensing, MHRA

 

 


 

 

 

Regulatory update in the USA

Jill Hartzler Warner, J. D., Acting Associate Commissioner for Special Medical Programs, US FDA

 

 

 

 


 

 

 

Experience from French Notify Body

Dr. Thierry Thomas, Head of Certification G-MED, LNE

 

Doctor of Pharmacy and holds a Diploma of Specialized Studies in Industrial Pharmacy and Biomedical.
After a industrial experience in the field of cardiovascular and interventional neuroradiology medical devices, he joined the National Metrology and Testing Laboratory in 1998 as Chargé d'affaires in the Division G-MED, French Notified Body. Auditor, assessor, he also carries out Quality System inspections under existing agreements with the U.S. Food & Drug Administration.
Since 2006, Thierry THOMAS is the General Manager of G-MED certification activities.

 

 

 

 


 

 

 

Experience from British Notify Body

Theresa Jeary, Certification Manager, BSI Healthcare

 

Theresa is a qualified Pharmaceutical Scientist and has 22 years experience in both the Pharmaceutical and Medical Device Industries, located in the UK, Ireland and Germany. She has worked in a variety of roles in these industries from product formulation development, transfer, validation, regulatory affairs for human and veterinary medicinal products and more recently was the R&D Manager for a medical device manufacturer, with responsibility for the development of several device drug combination products. Theresa currently works for BSI (Notified Body) in the UK as Certification Manager in the General Devices group, with particular responsibility for the co-ordination and management of Device – Drug combination products and consultations, classification of borderline products and as a technical reviewer, with particular emphasis on IVF Media and Solutions for Organ Transplantation. In her spare time Theresa is currently working towards obtaining a Qualified Person Qualification from the Royal College of Surgeons, Dublin.

 

 

 


 

 

 

Experience from German Notify Body

Dr. Wilma Hartung, General Manager Medical/Business Division Products, TÜV Rheinland LGA Products GmbH

 

 

 

 

Back to Programme