Webinar – EU Pharmaceutical Reform: Unveiling Draft Legislation Impacts

What: Webinar – “EU Pharmaceutical Reform: Unveiling Draft Legislation Impacts”
When: Thursday, February 29th, 2024, at 10:00 AM EST
Where: Online Event
How: Register Here
Why: This webinar will explore the context of EU pharmaceutical reform and help identify the main changes when compared to the current set of rules and regulations.

All registrants will receive a copy of the webinar recording following the live event. Register now and don’t miss out!

The flagship action of the Communication on Pharmaceutical Strategy for Europe has been the reform of the European pharmaceutical legislation. On 26 April 2023, the EU Commission submitted a new European proposed REGULATION and DIRECTIVE, which is the first momentous review of pharmaceutical legislations since 2004.

Join Marloes van der Geer, Senior Regulatory Affairs Scientist at Celegence for an informative webinar designed to support your understanding of how these changes may impact you and your organization, and how to better anticipate EU pharmaceutical reform changes. Don’t miss this opportunity to stay informed and equipped with practical knowledge of EU pharmaceutical legislation.

Have a question now? Submit it ahead of time and we will endeavor to provide you with a live answer during our webinar, submit your question here.

This webinar will include a 45-minute presentation and 10 to 15 minutes of Q&A.

Marloes van der Geer, Senior Regulatory Affairs Scientist

• Marloes provides regulatory affairs consultancy and services to both big- and small-sized pharmaceutical companies, covering a wide variety of products.
• Marloes holds a master in Life Sciences (Drug Innovation) from the University of Utrecht, the Netherlands. For nine years she held several positions at Hoffmann-la Roche in Switzerland, including the role of regulatory intelligence manager and regulatory policy lead for the EMEA region. Marloes has been actively involved in several industry associations like EFPIA and IFPMA. Also, she contributed to the ongoing IMI PREFER project in Europe, focused on the generation and use of patient preference data. In 2019, Marloes joined Qdossier, a Celegence company.
• Marloes’ areas of expertise are regulatory affairs (both HQ and affiliate focused), biopharmaceuticals (incl. biosimilars) development, regulatory convergence & harmonization, facilitated registration pathways (incl. orphan drugs), eCTD publishing and lean authoring.

• Get a high-level understanding of the Pharmaceutical Strategy for Europe
• Understand the main changes in the newly proposed European pharmaceutical legislation
• Anticipate how (foreseen) changes will impact you/your organization
• Get advice on how to prepare for the changes

This webinar is aimed towards regulatory professionals in the pharmaceutical industry, including middle and top level global regulatory professionals involved in: Regulatory Affairs, Medical/Regulatory Labeling/Scientific Writing, Regulatory Operations, Document and Project Management etc.

Celegence provides regulatory outsourcing services and can take either full responsibility for regulatory deliverables or engage remotely and/or on-site in operational activities within your company.

We are happy to share our insights with you during this webinar and hope that you can join us then.