On 30 April 2021, the draft of a regulation for completely new clinical trials of medicinal products for human use, which implements Regulation 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repeals Directive 2001/20/EC, was published for public consultation.
Pawel Hincz is a partner in Baker McKenzie's Warsaw office and head of the Life Sciences group. He has over 12 years of experience advising on M&A projects, with a focus on the health sector. He also provides regulatory advice to pharmaceutical manufacturers, manufacturers and distributors of medical devices, pharmaceutical wholesalers, pharmaceutical industry associations and medical service providers. Prior to joining the Firm, he worked in the Ministry of Health and practiced in various international and domestic law firms. Pawel often participates as a speaker in various conferences and is an author of a number of publications.