Event Listing

The Windsor Framework – SPC implications

6Nov

This webinar will provide an overview of the key regulatory changes arising from the Windsor Framework and their implications for Supplementary Protection Certificates (SPCs) in the UK. Designed for those without a regulatory background, attendees will gain insight into the recent changes to the UK medicines licensing regime, including the introduction of UK-wide marketing authorisations.  The session will also address the implications of these changes for pending and granted SPCs, the transitional provisions for SPC applications and provide guidance to navigate this evolving landscape.

Audience

All

Speakers

Dr. Beatriz San Martin, Arnold & Porter

Dr. Beatriz San Martin, Arnold & Porter

Dr. Beatriz San Martin has extensive experience in intellectual property matters with a particular focus on innovative and emerging technologies, particularly within the life sciences sector, as well as technology enabled solutions. She is sought after for her strategic input on the interplay and enforcement of intellectual property rights and trade secrets, her niche SPC experience, and her specialist knowledge of international treaties relating to genomic resources such as the Nagoya Protocol.

Her disputes practice is varied with significant and high-profile experience handling cases before the UK Courts and the Court of Justice of the European Union, coordinating cross-border European litigation and assisting in multinational arbitrations. She robustly manages and resolves disputes relating to the full spectrum of intellectual property rights, assists clients on challenging technical issues and provides strategic IP advice.

Prior to pursuing a legal career, Beatriz was a scientist with a degree, Ph.D. and postdoc specialising in genetics, cellular and molecular biology. This interest and passion in science and technology has broadened during the course of her legal career through her varied work with clients and involvement in trade associations.

Christopher Bates, Arnold & Porter

Christopher Bates, Arnold & Porter

Christopher is a member of the firm’s Life Sciences team. The main focus of his practice is advising pharmaceutical and medical devices companies on a range of regulatory issues across the product lifecycle, including product borderlines, clinical studies, regulatory exclusivities, marketing authorisations and CE marking, distribution, manufacturing, promotion, market access, and vigilance.

Christopher is particularly experienced in acting on advertising and industry code compliance matters, including copy review of promotional materials, advising on interactions with health care professionals, as well as acting in disputes under the ABPI Code and the ABHI Code. He also assists clients in developing internal compliance programmes and acts on internal investigations.

A key area of Christopher’s practice is advising on digital health technologies having advised start-ups, as well as leading technology, medical device, pharmaceutical, and insurance companies on regulatory matters, including on qualification and classification issues, conformity assessment, and the implications of the proposed EU AI Act.

Christopher also advises clients on pricing and reimbursement matters, including on the voluntary and statutory schemes for the pricing of branded medicines in the UK. His experience includes acting in disputes and negotiations with the Department of Health and Social Care.

Share this page

Shopping Bag (0)

No products in the cart.