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Congress Center Basel

Mar 17, 2025 1:00 PM - Mar 17, 2025 5:00 PM

Messeplatz 21 , CH-4021 Basel , SWITZERLAND

How to Navigate the Future Parallel HTA and EMA Processes in the EU

This course will discuss regulatory preparedness for the JCA process, explain the interface between regulators and EU HTA Coordination Group and which information is shared by the two. The instructors have been very close to the HTA Regulation implementation activities in companies and with the policymakers.

Early-Bird rate for DIA Industry Members Available!

DAYS

HOURS

MINUTES

SECONDS

Faculty

Inka  Heikkinen, MBA, MSc

Inka Heikkinen, MBA, MSc

Regulatory Policy Lead, Lundbeck, Denmark

Generalist with a broad understanding of policies across value chain in pharmaceutical and health sector. Stakeholder, alliance and project management expertise.

Nadege  Le Roux, PhD

Nadege Le Roux, PhD

Regulatory Policy Senior Director, Bristol Myers Squibb, Switzerland

As Senior Director of Regulatory Policy and Intelligence at BMS, Nadège is leading taskforces to evaluate the European regulatory framework in the perspective of global environment. She works with stakeholders to advocate for policies supporting development of innovative medicines and regulatory systems. She has worked in the pharmaceutical industry for over 20+ years and is currently focused on regulatory policies relating to the European pharmaceutical legislative ecosystem to advance innovation, orphan drug development, patient engagement as well as the modernization of the regulatory procedures via digitalisation.

Isabelle  Stoeckert, PharmD, PMP

Isabelle Stoeckert, PharmD, PMP

VP. Head Regulatory Affairs Europe Middle East Africa, Bayer, Germany

Dr. Isabelle Stoeckert is Vice President and Head Regulatory Affairs Europe Middle East Africa at Bayer AG. With more than 20 years of experience in Regulatory Affairs she held several leading positions in a wide area of Regulatory and Scientific Affairs matters. Such as Vice President, Head of Global Strategy and Director, Head of Regulatory Affairs International at Bayer HealthCare AG. She is member of several EFPIA committees.

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