Andrea Zrener

Responsible to ensure Companies compliance with pharmaceutical regulations and laws as well as providing expertise on drug safety and medical topics. Provide medical expert advice to ensure proper development and promotion of new products. Develop medical product information and stay informed on scientific trends and competition. Trains local teams in medical governance topics.

Maintain and enhance governance and setting of standards for medical programs, i.e. local studies, non-interventional studies, managed access programs and investigator initiated studies. Develop, implement, and deliver training to ensure processes and standards are fully understood and associates are educated. Support readiness for Health Authority inspections and internal audits

Implementation of Quality Standards and processes for the conduct of local medical activities and projects within the country organisation. Compliance Review from medical perspective. Development of local processes and Quality Standards for the conduct of local clinical studies and projects.222

Approval of all compliance-processes according to legal requirements as per Germany Drug Law §74a (as well as in accordance with the German Ordinance on the Production of Pharmaceuticals and Active Substances (AMWHV), Advertising of Medicines Act (HWG), FSA-Code of Business Practice and valid guidelines as per delegation from the Information Officer according to German Drug Law §74a in an electronic approval workflow and setup system.

Medical and scientific support for the development and planning of scientific projects in different indications according to legal regulations and the FSA-Codex. Correspondence with regulatory authorities and ethics committees according to German drug law (AMG) and relevant regulations. Submission of clinical trials to BfArM (German Health authority), regional council and Ethics Committees as per Germany Drug Law and GCP-Guidelines for clinical studies (interventional and non-interventional.

(Acting) Clinical Monitoring Manager for Germany and Austria - (home based) Functions: Manage the Clinical Monitoring organisation in Germany and Austria. Local expert for site and study management. Maintain excellent relationships with trial sites and Merck Serono’s commercial organisation in the country.

Principal Clinical Research Associate (home-based) - since April 2005. - Functions: Oversee the conduct of clinical trials at assigned trial sites, within the agreed time-scale, by regular monitoring. Mentor and Coach to more junior CRAs. - Jan 1998-March 2005 - Senior Clinical Research Associate (home based) Functions: Monitoring of clinical trials in several therapeutic fields Reproductive Endocrinology, Neurology, Dermatology, Rheumatology, Oncology, Paediatric Endocrinology.

Clinical trial (CT) protocol writing and designing CRFs. Development of programs for computer-assisted data entry of CT data. Data entry and verification of clinical trials data. Documentation of CTs as per contemporary scientific and legal standards. Monitoring clinical trials in Germany and Austria in Neurology, Cardiology, Dermatology. Responsible for Training of junior CRAs