Angelika Joos is a licensed pharmacist. Since 2001, she is responsible for regulatory policy issues at Merck Sharp & Dohme's Regulatory Affairs department in Brussels. Over the past 17 years, Angelika has gained strategic as well as operational experience with all regulatory procedures and various products in different therapeutic areas.
In her current position as Head Regulatory Policy EU & Most of World she is responsible for monitoring and implementing regulatory policies and procedures and advising the company on regulatory strategies.
She represents MSD in the EFPIA Scientific Regulatory and Manufacturing Policy Committee and in the IFPMA Regulatory Policy Committee. Her main interests are related to clinical trials, pharmacovigilance, HTA and paediatrics.
She has been a member of the DIA Advisory Council Europe since 2008 and has been involved in the organisation of several DIA Forums as well as two DIA EuroMeetings.
Dr Christa Wirthumer-Hoche studied biochemistry and graduated from the Technical University, Vienna in 1981. She did her doctoral thesis at the Institute for Medical Physiology, graduating in 1983 then joined the Austrian National Institute for Quality Control of Drugs in 1983, 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 is Head of Institute for Marketing Authorisation and Lifecycle Management of Medicinal Products and she was appointed Head of the Austrian Medicines and Medical Devices Agency on 1 October 2013.
Dr Wirthumer-Hoche has also 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). In Dec.1999 she was appointed by the European Commission as Co-ordinator for the CTD Implementation in Europe (ICH-IWG). She is the Austrian Delegate in the Coordination Group for Mutual Recognition and Decentralised Procedures for human MPs (CMD-h) and chair of the Joint Working Group on ASMF-procedures.