Salary Partner
Irina is member of the Practice Area Patents Technology & Life Sciences and the Life Sciences & Healthcare Industry Group. Her practice includes advising pharmaceutical, medical device, and biotechnology companies and investors on all regulatory matters throughout the entire life cycle of medicinal products, medical devices, and IVDs: from preclinical research and clinical trials, manufacturing, and market access to distribution (including post-market surveillance).
She also provides legal advice on genetic engineering, food (including food supplements), and cosmetics. Irina complements this practice focus by drafting and negotiating corresponding industry-specific agreements (including research and development agreements, license agreements, clinical trial agreements, contract/manufacturing and distribution agreements (including quality agreements)) and by advising on (cross-border) transactions in the healthcare sector.
§§ 40-42e AMG in: Rehmann, AMG, 6. Aufl. [in Bearb./vor. Anfang 2026] § 15 Entwicklung des Arzneimittelprüfrechts
§ 16 Grundlagen klinischer Arzneimittelprüfungen
§ 17 Zentrale Voraussetzungen klinischer Prüfungen im Überblick in: Spickhoff/Handorn: Handbuch Medizinisches Forschungsrecht, C. H. Beck, München, 2023
§ 2 ProdHaftG im Beck-Online-Großkommentar (seit 2015)
Law firm of the year for IP Law
The 2026 Pharma Package: A New Regulatory Framework for Medicinal Products in the EU
A European Perspective #1 | The EU’s largest pharmaceutical law reform in over 20 years introduces a new regulatory exclusivity framework, revised orphan drug incentives and an antimicrobial voucher. Strategic exclusivity planning will become essential for pharmaceutical companies.
by Irina Rebin
1 of 9 Insights
No claim for damages as a result of participation in clinical drug trials
A European Perspective #1 | GERMANY | The Frankfurt am Main Regional Court confirms: No reduction in the burden of proof (presumption of causality) pursuant to Section 84 (2) of the German Medicines Act (AMG) for IMP (not even by analogy) and no liability on the part of the sponsor in the event of (insufficient) risk information provided by the investigating physician.
by Irina Rebin
7 of 9 Insights
by multiple authors
by multiple authors
by multiple authors
by multiple authors
by Katie Chandler and Matthew Caskie