AJW Legal Consulting

Anja J. Weissbrodt

 

Rechtsanwältin | MBA | LL.M. | Cert. Healthcare Compliance OfFicer



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Anja J. Weissbrodt


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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

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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





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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




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Nehmen Sie Kontakt mit mir auf. Ich berate Sie gerne in Ihrem Anliegen.



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