Dr. Anja Weissbrodt

Background

General Business Support

• Drafting/reviewing/advising on commercial, R&D, clinical, sponsoring and other types of agreements
• Maintain contracts database
• Advising on all legal questions related to medicinal products (e.g., Arzneimittelgesetz „AMG“)
• Advising on risks related to promotional and scientific activities with a view to the Heilmittelwerbegesetz („HWG“) and FSA-Code of Conduct (FSA-Kodex)
• Advising and training on competition law (Kartellgesetz) and unfair competion law (Gesetz gegen den Unlauteren Wettbewerb „UWG“)
• Litigation support (civil/administrative/criminal), including unfair competition preliminary proceedings (HWG, UWG)
• Representing Company at the FSA and VfA meetings

Regulatory Affairs & Value and Access

• Advising in connection with health technology assessments, including interactions with German reimbursement authorities like the Gemeinsamer Bundesausschuss (G-BA)
• Supporting external inspections and internal audits
• Advising on tender, pricing and reimbursement-related issues

R&D Support

• Advising on issues related to clinical trials, non-interventional studies and investigator-initiated studies (contracts and interpretation of law)

Compliance

• Advising on appropriate interactions with health care professionals and health care organizations
• Advising local grants and donations committee
• Training on anticorruption/FCPA

Corporate Administration

• Advice and assistance on various corporate administration matters
• Administrative and supervisory matters
• Assistance in managing external counsel and budget issues

R&D Matters

• Support of clinical studies, non-interventional studies, ISSs and related matters
• Advising staff on contracts covering third existing party relationships

Transition Services

• Provide transition services and other support relating to the transfer of processes, procedures and know-how relating to the provision of the legal support for Company and affiliates from the departing Senior Counsel to a new permanent attorney

Resume