Case studies

Pharmaceutical law team

Selected credentials

Advertisement of medicinal products

Issuing opinions regarding promotional materials for a number of leading pharmaceutical companies.

Assessments of risks involved in social campaigns and distribution of press releases on the technical progress related to bringing innovative products to the market to the media.

Representing international pharmaceutical companies in proceedings before the Main Pharmaceutical Inspectorate.

Exchanging correspondence with competitors concerning promotional materials used by them.

Development of arguments for purposes of proceedings before the industry disciplinary court for a leading U.S. pharmaceutical company.

Drafting and negotiating contracts used for purposes of promotional activities at the request of a number of international pharmaceutical companies.

Drafting and negotiating a co-marketing agreement for a leading U.S. pharmaceutical company.

Drafting Internet platform implementation agreements for a leading U.S. pharmaceutical company.

Development and reviews of marketing procedures for a number of international pharmaceutical companies.

Organization of workshops dedicated to promotion of medicinal products and medical devices for a number of clients.

Application for interpretation of specific legal provisions by the Main Pharmaceutical Inspectorate for Swiss pharmaceutical companies.

Preparation of analyses of the effects of implementation of new regulations applicable to advertising medicinal products for international pharmaceutical companies.

Issuing opinions regarding a number of miscellaneous issues for global pharmaceutical companies.

 

Distribution of medicinal products   and competition law

Development of distribution models for numerous global pharmaceutical companies and advising clients on product price reductions.

Representing a German and UK pharmaceutical company in proceedings concerning classification of borderline products.

Advising a Swiss pharmaceutical company on the obligations related to importing products to Polish clients.

Conducting parallel import proceedings for a number of global pharmaceutical companies.

Development of a legal strategy related to bringing a generic product to the market at the request of innovative pharmaceutical companies.

Drafting various sector agreements, to include distribution agreements, general terms of sale and warehousing agreements.

Review of model agreements in terms of their compliance with industry codes and the applicable laws, including competition law.

Analysis of discount policies used in distribution of medicinal products and medical devices in terms of their compliance with competition law.

 

Clinical trials

Drafting model agreements and implementation of global model agreements on clinical trials and non-interventional studies at the request of global pharmaceutical companies and CRO.

Negotiating clinical trial and observational study agreements for a number of U.S. and a Swiss pharmaceutical company.

Advising a U.S. and a Danish pharmaceutical company on the terms of clinical trial financing.

Advising a U.S. pharmaceutical company and a global CRO on the terms of granting consent in clinical trials.

Drafting and negotiating agreements between the sponsor and CRO for a global U.S. company.

Representation of an international company – sponsor in proceedings before the Central Register of Clinical Trials.

Issuing legal opinions regarding sponsor’s obligations in relation to clinical trials conducted by international pharmaceutical companies.

Analyses of informed consent forms in terms of their compliance with the applicable laws, including the personal data processing rules, for global pharmaceutical companies and leading CROs.

 

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