Agenda

16:00

Welcome and introduction by our Mentor

Ingrid Klingman

 

Ingrid KLINGMANN MD, PhD, FFPM, FBCPM

PHARMAPLEX bv, EUFEMED, PharmaTrain Federation, EFGCP

Physician, specialized in General Medicine, Clinical Pharmacology and Pharmaceutical Medicine with over 30 years of experience in different senior medical, operational and managerial functions in pharmaceutical industry, CROs and clinical trial sites with focus on clinical trial design and management, ethical and regulatory aspects.

Since January 2003 she has her own pharmaceutical development and site management support consulting company.

Dr Klingmann is Chairman of the Board of the European Forum for Good Clinical Practice (EFGCP).

Dr Klingmann is currently also Secretary of EUFEMED, the European Federation of Exploratory Medicines and President of PharmaTrain Federation, the not-for-profit organisation focussing on global standardisation and improvement of post-graduate training in medicines development sciences. She also teaches on different clinical research and regulatory affairs topics in diploma and master courses at the University of Bonn, Germany, University of Basel, Switzerland, and the Université Libre de Bruxelles, Belgium.

 

16:10

TITLE 1

Ewa Oldak

 

Ewa Oldak, PhD

Director at Department for Clinical Trial of Medicinal Products

BIO

16:25

TITLE 2

Marek Czarkowski

 

Marek Czarkowski, MD, Prof.

Chairman of the Bioethics Center of the Supreme Medical Council, chairman of the Bioethics Committee at the Regional Medical Chamber in Warsaw

BIO

 

16:40

TITLE 3

Greet Musch

 

Greet Musch, PhD

Director General at Belgium’s Federal Agency for Medicines and Health Products (FAMHP)

Mrs Greet Musch has obtained a PhD in Pharmaceutical & Biomedical Sciences from the Free University Brussels. She joined the Pharma Industry for 8 years as responsible for all the chemical and pharmaceutical analytical activities related to the development of new innovative drugs. Afterwards, she joined the Federal Public Health services as senior quality assessor. Between 2004 and 2009 she was in charge of the R&D department. On February 2009 she has been designed as Director-general for the DG Pre-authorisation at the FAMHP.

16:50

TITLE 4

Gerd Mikus

 

Gerd Mikus, MD Msc

Vice-chairman of the Ethics Committee, State Medical Association of Baden-Württemberg

BIO

17:00 – 17:30

ROUND TABLE DISCUSSION

Ewa Oldak, PhD
Marek Czarkowski, MD, Prof.
Greet Musch, PhD
Gerd Mikus, MD Msc
ICON
Agnieszka Kulesza