• Business driven strategic & pragmatic approach
  Having worked many years in the industry I am focusing on solution oriented advice to help the business accomplish their goals, balancing risks and efficiencies. I understand what clients want and can interpret the legal and regulatory framework from a pragmatic perspective.
  
  I can consult on an ad hoc basis or I can assist to design a proactive legal and compliance framework.
  

• Both external support & in-house experience
  My experience with the two types of support allows me to offer flexibility in the service offering. I can either consult on specific issues you may have or smoothly integrate your teams to work on a specific project or to offer temporary replacement of a legal or compliance position.

• Unique expertise in Research & Development (R&D)
  I can lead you through the hurdles of setting up a multi-country trial from a regulatory, legal and compliance perspective. By setting up proactively the right framework we can speed up start up times and design the optimal research strategy while mitigating the numerous risks encountered.
  
  If this is your first trial in Europe I can help you understand at a glance all the challenges and give you the upfront legal and compliance advice needed to succeed.
  
  I have extensive experience in the design of legal and compliance documentation & process in all key regions (European Economic Area, Latin America, Asia, North America).
  I can assist you in getting a drug to the market and/or ensuring patient access ahead of drug approval.
  
  Based on my experience in R&D I can also support the creation or adaptation of the compliance program for the medical and R&D activities.

• Broad life science legal & compliance experience
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Research & development (R&D) legal and compliance matters

• Regulation of medicinal products, both pharmaceuticals and biologicals

• Clinical trials legal framework

• Contract design and negotiation

• Key expertise in particular with respect to:
  
  • Clinical Research Organizations (CROs) and other clinical vendors
  • Clinical sites
  • Patient interactions
  • Informed consent forms
  • Secondary research
  • Data Privacy
  • Pharmacovigilance/drug safety
  • Regulatory
  • Patient claims mitigation
  • Early access programs

   

• Develop risk awareness and establish adequate levels of control

• Design all relevant legal and compliance processes to maximize efficiencies

• Prepare and deliver adequate trainings to ensure impactful implementation of the above

I created Pharma Law Solutions in 2015 in order to provide tailored legal and compliance advice to the pharmaceutical, medical devices and biotech companies in all different aspects of their activities (commercial, regulatory, research & development (R&D) and compliance).

Previously I have held different lead roles at Biogen in the Legal and Compliance department. My last role was Head of Compliance for Europe and Canada.  In my role, I was responsible for the development, coordination and implementation of the Biogen Corporate Compliance Program.

Prior to this Compliance role, I have had lead roles in the Commercial and R&D legal support. Within my Commercial Legal role I was the lead lawyer for the European competition matters, and the dedicated lawyer for distribution markets as well as the trusted advisor to the business in the following regions: Latin America, Benelux, France, Spain and Portugal, Canada. Within my R&D role I was responsible for the provision of legal advice to the Global Clinical Operations function and supported the Medical Affairs, Pharmacovigilance and Regulatory departments.

Prior to working with Biogen, I was working in the M&A department of the International law firm Freshfields Bruckhaus Deringer. I am admitted to the French (Paris) bar. 

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Sandoz International GmbH

Research & development (R&D) legal and compliance matters

• Regulation of medicinal products, both pharmaceuticals and biologicals

• Clinical trials legal framework

• Contract design and negotiation

• Key expertise in particular with respect to:
  
  • Clinical Research Organizations (CROs) and other clinical vendors
  • Clinical sites
  • Patient interactions
  • Informed consent forms
  • Secondary research
  • Data Privacy
  • Pharmacovigilance/drug safety
  • Regulatory
  • Patient claims mitigation
  • Early access programs

   

• Develop risk awareness and establish adequate levels of control

• Design all relevant legal and compliance processes to maximize efficiencies

• Prepare and deliver adequate trainings to ensure impactful implementation of the above

Pharma Law Solutions GmbH
Magalie Wasem Tréguer
Säntisstrasse 93
CH-8820 Wädenswil
Switzerland

+41 79 290 47 46
mwasem AT pharmalawsolutions DOT com

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