Prof. Dr. rer. nat. Barbara Sickm?ller is a pharmacist. She studied and obtained her doctorate at the Philipps University in Marburg - Germany (1967-1974).

From 1977 she worked as a scientific executive at the Association of the German Pharmaceutical Industry (BPI) and took over the section "Drug Safety" of BPI in 1979. 1984/1985 she had a sabbatical year in the USA with training into US drug legislation. From 1988 she was appointed as head of the department "Medical affairs" and from 1997 Director of the Medicines and Pharmacy Division of BPI. In 2000 she was appointed as Deputy Director General of BPI.

Since 1987 until 2011 she gave yearly lectures in the department of Pharmacy, University of Marburg, and was appointed honorary Professor of the University of Marburg/Lahn (Januar 2000). In addition, she gave lectures for the Master of Drug Regulatory Affairs at the University in Bonn. She had further teaching assignments at the Universities of Frankfurt and Heidelberg on Pharmacovigilance and clinical trials, and has published numerous publications and book contributions in these regulatory areas.

The German Ministry of Health appointed her as Member of the Advisory Committee on prescription of pharmaceutical products, the Commission on Medicines for Children and Adolescents (KAKJ) and member of the Board of Trustees of the Institute for Quality and Efficiency in Health Care (IQWiG) and a member of the Board of Trustees of the German Agency for Health Technology Assessment (HTA) at DIMDI.

She was member of several Working Groups of the Council for International Organizations of Medical Sciences (CIOMS) and the International Council for Harmonization of Marketing Authorization Requirements (ICH) in the areas of pharmacovigilance and clinical trials.

Since March 2012 she has retired and is now active as Senior Scientific Advisor for BPI. Furthermore,she gives lectures on Pharmacovigilance and clinical trials at the Universities in Bonn, Heidelberg and Marburg.

In July 2014 she was appointed President of the German Association for Regulatory Affairs (DGRA)in Bonn and in October 2014 as member of the university council of the University of Applied Sciences of Central Hesse (THM) in Gie?en.

Dr Brigitte Franke-Bray is an Independent Consultant with special expertise in Pharmaceutical Medicine. From September 2018 to March 2023 she was Treasurer and Board Member of IFAPP (ifapp.org) and still is a Board Member of PharmaTrain (pharmatrain.eu) and a member of the Advisory Board of ECPM (ecpm.unibas.ch). She has also been a board member of SGPM (sgpm.ch) for many years and a member of EUPATI (eupati.ch). She worked as a hospital physician in internal medicine, pneumology and allergology in Germany, then joined Ciba-Geigy in 1985 and afterwards Sandoz as a Medical Expert for respiratory diseases. In 1995 she joined Quintiles as Medical Director/Office Head Switzerland became Director DIA (diaglobal.org) Europe, Middle East, Africa, in 2005 and, additionally, the DIA's Global Training Officer. In 2013, she was a Clinical Reviewer at the Swiss Medicines Regulatory Authority Swissmedic in Marketing Authorisation before she became a globally acting Medical Director in the Respiratory Franchise in Novartis Basel, Switzerland, then started her consultancy in Pharmaceutical Medicine in 2018. Dr Franke-Bray has ample experience in Pharmaceutical Medicine education and training, also through the IMI (imi.europa.eu) projects PharmaTrain and EUPATI. She was a teacher and examiner at a diploma course at the University of Basel, Switzerland, and is a regular examiner at Basel University’s ECPM training course and also for the board-certified physicians’ specialisation in Pharmaceutical Medicine in Switzerland.

Christa WIRTHUMER-HOCHE, Dr. techn., Dipl. Ing.

DI Dr. Christa Wirthumer-Hoche studied biochemistry and graduated at the Technical University, Vienna in 1981, she did her doctoral thesis at the Institute for Medical Physiology, graduating in 1983. She joined the Austrian National Institute for Quality Control of Drugs in 1983 until May 1998, focusing on the assessment of quality documentation. From June 1998 until December 2005 she was the Head of the Licensing Division for medicinal products, in the Unit for Pharmaceutical Affairs in the Austrian Federal Ministry of Health and Women.

Since the founding of the new Austrian Agency 1 January 2006 her position was Head of the Unit for Marketing Authorisation and Lifecycle Management of Medicinal Products, in 2013 she was appointed Head of the Austrian Medicines and Medical Device Agency at AGES Austrian Agency for Health &Food Safety, until she retired in 2023.Since 1994 she has been involved in different European committees and working groups (CPMP/CVMP Quality Working Party, the Committee for Proprietary Medicinal Products (CPMP), MRFG, Notice to Applicants Group, in the PERF project). She was the Austrian delegate for the Coordination Group – Mutual Recognition and Decentralised Procedure human (CMDh), and also the chair of the Joint Working Group on ASMF-procedures, as well as a member of the European Risk Management Strategy Fascilitation Group (ERMS).In Dec.1999 she was appointed by the European Commission as Co-ordinator for the CTD Implementation in Europe (ICH-IWG).

As Head of the Austrian Agency she was a member of the Heads of Medicines Agency Group (HMA), a member of the EMA-Management Board, and from 03/2016 – 03/2022 elected Chair of the EMA-Management Board. Together with EMA she was co-chairing the EU- Network Training Centre.

She is a frequent speaker at numerous international and European meetings. Further she is a lecturer for post-graduate studies “Master of Regulatory Affairs” at the University in Vienna (Austria), in Bonn (Germany) and Copenhagen (Denmark).

Dr Birka Lehmann is Senior Expert for Drug Regulatory Affairs and Lecturer at the University of Bonn since 1998.

Birka Lehmann studied Medicines at the Free University Berlin and trained at the Kinderklinik Norderney. Her working experience includes 9 years preclinical assessment in the division ‘Pharmacology and Toxicology’ of BfArM and she served as head of unit ‘Decentralised Procedure’ (1996-2002) and as deputy head of EU Division (2000-2002). She was member of and chaired the Mututal Recognition Facilitation Group and served as expert to the Committee for Human Medicinal Products (EMA).From 2002 – 2006 she joined the European Commission, Directorate-General Enterprise and Industry as expert on secondment to in the unit ‘Pharmaceuticals’ responsible for inter alia Marketing Authorisation and implementation of Clinical Trials Directive.From September 2006 till October 2011 she was head of the division 3 Marketing Authorisation procedure at the BfArM compromising several indication areas including cardiovascular and pulmonary disease, antibiotics and dermatology.She was head of Executive Department EU and International Affairs of the Federal Institute for Drugs and Medical Devices (BfArM) from October 2011 till end of 2015. She was member of the Paediatric Committee at the European Medicines Agency from 2007 till 2016.