Dr. Tina Welter-Birk

Dr. Tina Welter-Birk

Senior Associate

Email [email protected]​hoganlovells.com

Phone +49 89 290 12 0

Fax +49 89 290 12 222

LanguagesEnglish, French, German

Practice groupGlobal Regulatory

As a member of our highly respected Life Sciences team, Tina Welter-Birk is constantly entrusted with commercial and regulatory matters for clients in the pharmaceutical, biotech and medical devices industry. Tina assists her clients during the whole product life cycle, from the early stages in product development, to marketing approval and advertising.

She also helps clients to identify compliance risks in collaborations with health care professionals. With her background in social security law, one particular focus of her practice lies in the handling of reimbursement matters and other matters relating to the statutory health insurance. Tina has extensive expertise in supporting worldwide clinical trials for medicinal products and medical devices in regulatory and contractual matters. In addition, she assists in the drafting and negotiation of complex agreements in the life sciences industry, for example in connection with mergers and acquisitions or drug development collaborations.

As part of her legal education, she worked for several international law firms in Frankfurt and assisted a Higher Social Court. Before joining Hogan Lovells, Tina worked for a boutique law firm in the health care sector and was an academic assistant to the Chair of civil law, German and European economic law and private insurance law at the Saarland University. Designated as member of the University's "excellent female scientists", she wrote a thesis on occupational disease in social and constitutional law context, which was honored with highest praise.

Awards and recognitions


Recommended Lawyer for Industry focus: Healthcare
Legal 500 Germany

Education and admissions


Second State Exam in Law, Higher Regional Court of Saarland

First State Exam in Law, Saarland University

Dr. iur., Saarland University

Representative experience

Advice on COVID-19 related matters (e.g. manufactur and import of face masks/face shields, conduct clinical trials and stockpiling of medicinal products by the government).

Advising various pharmaceutical companies on regulatory and commercial questions regarding advanced therapy medicinal products (ATMPs).

Drafting of license and other agreements for the development and marketing collaboration between pharmaceutical companies.

Analysis of the compliance system of the German affiliate of an international pharmaceutical company.

Advising an international pharmaceutical company on a referral in connection with a mutual recognition procedure (MRP).

Advising on regulatory and commercial questions around health apps.

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