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Welcome to the January 2020 edition of our newsletter. The EMEA Healthcare Industry Group Newsletter is your regular digest of legal developments affecting the life science and healthcare industries across the region.

 


In this issue:

Webinar: International Data Transfers (in conjunction with MedTech Europe)

Baker McKenzie and MedTech Europe are co-organizing a webinar on international data transfers focusing on Russia, the Middle East and Africa on the 3 February from 14.00 pm to 15.00 pm CET.

Our aim is to provide you with an overview of the different data protection landscapes of those countries and regions and to discuss the implications of international data transfer restrictions as well as the impact of GDPR.

Should you have any specific questions for the Q&A part beforehand, please send them to c.marcon@medtecheuropeorg by Thursday 30 January. A comment-box will also be at your disposal during the webinar.

Agenda

  1. Welcome and introduction
  2. Data protection landscape in Russia, Middle East, Africa
  3. International Data transfer restrictions
  4. GDPR impact
  5. Q&A

Featured Speakers

 MedTech Europe

  • Chantal Vets, Legal Director, Medtronic, and Chair of MedTech
  • Europe’s Data Protection Committee

Baker McKenzie

  • Darryl Bernstein, Johannesburg
  • Kellie Blyth, Dubai
  • Janet MacKenzie, Johannesburg
  • Vadim Perevalov, Moscow
  • Jaspreet Takhar, London

Please join us via conference call (details below):

Join by phone

Toll number: +3228954374 (Dial-in Number)

Conference ID: 691623267#

For more information, please contact Julia Gillert or Bridget Fair.

Europe

  • Data protection and scientific research: Top 10 takeaways from the EDPS’s preliminary opinion
  • EU Judgment on the refusal of a Marketing Authorization for schizophrenia product
  • Incoterms 2020 -  What you need to know
  • Clinical trials of medicines: the European Commission publishes new documents for sponsors
  • Supplementary protection certificates for second medical uses (Case C-673/18 (Santen)): Advocate General Pitruzzella asks CJEU to finally make a clear choice about Neurim

Czech Republic

  • New medicine price controls

Hungary

  • OGYÉI issues draft guidance on medicine promotion

Italy

  • Proposed amendment to the Regulation EU 745/2017 to extend deadline for manufacturers of Class I medical devices
  • Registration in the Italian Register of medical devices is a requirement for participating in public procurement procedures
  • Biosimilars: the Administrative Court upholds the resolution of Tuscany Region on the prescription modalities

Netherlands

  • Class Action Act enters into force in the Netherlands

Sweden

  • New agreement on rules of cooperation between the pharmaceutical/medtech and the healthcare sector in Sweden

Turkey

  • TÄ°TCK updates guidelines for clinical trial applications
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