Anja J. Weissbrodt
Focus:
Outside Legal Counsel / Healthcare
Compliance Officer
• Legal Advisory
• Compliance and Data Protection
• External Compliance Officer
• Legal Intelligence
• Contract Management in Biopharma &
Medical Sector
• Legal Change Management
• Support of M&A Transactions /
Divestitures
Practice Areas / Expertise
• Legal advice, with focus on Contract
Management / M&A
• Strong understanding of economic
relationships (ability to read annual
reports,
cash flows and land register data and
estimate their influence)
• Focus on Medical & Pharmaceutical
Relationships
• High load-bearing capacity
• Structured and organized action
• Clear analytical skills
• Fast adaptation to changing situations
Experience / Selected Projects
CRO
Supporting an experienced CRO, which offers 360° customer support in Clinical Trials for phase I – IV as
well as for NIS (Non Interventional Trials), with regarding questions of Pharmaceutical Law and Data
Protection
CMO
Supporting CMO (or Contract Manufacturing Organizations) facilities, owned by a specialized Spanish
pharmaceutical company, dedicated to research, development, manufacture and marketing of small
molecules and biologicals, regarding questions of Pharmaceutical Compliance
Global API Provider
Acting as Outside Legal Counsel for a company for Active Pharmaceutical Ingredients and Intermediates
for the human and animal health industries
Global Radiopharmaceutical
Company
Supporting the Legal Department as Outside Legal Counsel in all matters
Global Leading Generics
Manufacturer
Supporting the Legal Department as Outside Legal Counsel in all matters
Global Leading Generics
Manufacturer
Supporting the Legal Department as Outside Legal Counsel in all matters; External Compliance Officer
Global Biopharma Company,
Frankfurt headquarters
Supporting the Legal Department as Outside Legal Counsel in all matters, Review, Amendment & Approval
of NDAs, MTAs & Cooperation Agreements et al. across all their sub-institutes
Leading German Research
Organization
Review, Amendment & Approval of NDAs, Cooperation Agreements et al. across all their sub-institutes
Global Biopharma Company
(Orphan Drug
Supporting the complete pre-launch process in 2016; legal and regulatory support post launch in
January/February 2017; Compliance support rg. BPI / AKG; new product launch in 2019 – all over DACH
Global Biopharma Company
(in Coop. with a leading International
Law Firm)
Review and Approval of CDAs and CTAs for 2 Clinical Trial studies in the field of therapeutic antibodies
Concerning sites all over Europe and the US
Global Biopharma Company
General Business Support
o Drafting/reviewing/advising on commercial, R&D, clinical, sponsoring and other types of
agreements
o Maintain contracts database
o Advising on all legal questions related to medicinal products (e.g., Arzneimittelgesetz (AMG))
o Advising on risks related to promotional and scientific activities with a view to the
Heilmittelwerbegesetz (HWG) and FSA-Code of Conduct (FSA-Kodex)
o Advising and training on competition law (Kartellgesetz) and unfair competion law (Gesetz gegen
den Unlauteren Wettbewerb (UWG))
o Litigation support (civil/administrative/criminal), including unfair competition preliminary proceedings
(HWG, UWG)
o Representing Company at the FSA and VfA meetings
Regulatory Affairs & Value and Access
o Advising in connection with health technology assessments, including interactions with German
reimbursement authorities like the Gemeinsamer Bundesausschuss (G-BA)
o Supporting external inspections and internal audits
o Advising on tender, pricing and reimbursement-related issue
R&D Support
o Advising on issues related to clinical trials, non-interventional studies and investigator-initiated
studies (contracts and interpretation of law)
Compliance
o Advising on appropriate interactions with health care professionals and health care organizations
o Advising local grants and donations committee
o Training on anticorruption/FCPA
Corporate Administration
o Advice and assistance on various corporate administration matters
Administrative and supervisory matters
o Assistance in managing external counsel and budget issues
R&D Matters
o Support of clinical studies, non-interventional studies, ISSs and related matters
o 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 knowhow relating to the provision of the legal support for Company and affiliates from the departing Senior
Counsel to a new permanent attorney
Hightech Start-up
Contract Draft and Negotiation
• Draft and negotiation of company agreements, licence contracts
• Legal Advice on patent contracts and patent administration
Global Biopharma-Group
Contract Center of Excellence
• Single responsibility for drafting, negotiating and finalizing templates as well as check of third party
contracts for Germany, Austria, Switzerland and the CIS in the areas of Commercial, Research &
Development and External Staff
• Managing input and output of all kinds of contracts as kind of single contact
• Close relationship to Procurement, Facility Management and HR
• Legal support of both divestitures and M&A transactions
