NDA, the leading European regulatory affairs consulting group, appoints Dr Panos Tsintis to its expanding panel of ex-regulator EU experts – the NDA Advisory Board and also to the position of medical advisor to NDA Regulatory Science Ltd. Dr Tsintis was previously head of sector, pharmacovigilance, post-authorisation safety and efficacy of medicines for human use at the European Medicines Agency and before that was responsible for pharmacovigilance for the UK MHRA.
The NDA Regulatory Expert Advisory Board is chaired by Prof Kjell Strandberg and has Dr Markku Toivonen as Scientific Director. Other ex-regulator members include Dr Manfred Haase, Dr Frits Lekkerkerker, Dr Gabriele Schäffner-Dallmann and Dr Mary Teeling. The NDA Advisory Board also includes other prominent experts, and its purpose is to provide clients with high level scientific advice from the viewpoint of recent European regulators with the aim to facilitate good drug development leading to a fast and positive assessment of marketing authorisation applications.
Dr Tsintis is a physician with broad experience in internal medicine: cardiology, respiratory medicine, gastro-enterology, hepatology, clinical pharmacology, diabetes/endocrinology, resistant epilepsy.
During his tenure of appointment at the EMA (2002-2008) Dr Tsintis was involved in all post licensing activities, major variations, extensions of indications, safety referrals, and pharmacovigilance and risk management. He took the lead for risk management planning at agency level and was co-lead for pharmacovigilance inspections. He was a core member of the EMEA crisis management team with hands-on involvement in all major safety issues. He was involved in a wide number of EMA committees (CHMP, Pharmacovigilance Working Party (PhVWP), Herbal Committee, Paediatric Committee, COMP, CMDh, Scientific Advice Working Group, Heads of Medicines Agencies European Risk Management Strategy facilitation group) and with Expert Groups (drug-related topics, pandemic flu, WHO, vaccines, paediatrics etc). Dr Tsintis was responsible for the EudraVigilance post-marketing and clinical trial modules and was involved in the development of other databases (Interim Pharmacovigilance Access, EudraPharm, Tracking databases in Pharmacovigilance and risk management, THIN/EPIC database).
In the international setting Dr Tsintis was a member of CIOMS and ICH working groups (PSUR addendum, MedDRA SMQs, E2E pharmacovigilance planning, signal detection CIOMS VIII) and will co-lead as independent expert the new CIOMS IX topic on pharmaceutical risk management, which is due to start formally in Q1, 2010.
Managing director of the NDA Advisory Board, David Gilbert, said: “Dr Tsintis brings considerable regulatory experience from his work both as a senior regulator in highly respected EU Health Authorities and also as a regulator on the international stage. The NDA Advisory Board presents a team approach to provide solutions for clients and Dr Tsintis is a welcome and important addition to that team. The new position of medical advisor is also an important one for the growth of NDA and for support for our 100 regulatory professionals.”