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Congress Center Basel

2025 年 03 月 17 日 1:00 下午 - 2025 年 03 月 17 日 5:00 下午

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

讲师团队

Inka  Heikkinen, MBA, MSc

Inka Heikkinen, MBA, MSc

Regulatory Policy Lead, Lundbeck, Denmark

Inka has been involved very closely in HTA Regulation implementation at EFPIA since the very beginning. She leads EFPIA workstream around regulatory-HTA interaction and Joint Scientific Consultation, with extensive work on defining industry positions and thinking around the future processes and system on Marketing Authorisation review process and Joint Clinical Assessment. As her day job, she leads R&D and regulatory policy strategy and operational excellence at Lundbeck, working with senior leaders defining and advocating for policies that optimizes the environment for future health technologies. Inka holds master degrees on health economics and in policy, an Executive MBA degree with specialisation in finance.

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

Independent Regulatory Science Expert, Independent, Germany

Dr. Isabelle Stoeckert has spent 30 years in various leading positions in Regulatory Affairs in the pharmaceutical industry. Until 11/2024 she served as Vice President Regulatory Affairs EMEA at Bayer AG. Prior to that she gained global experience as Head of Global Strategy Pharma and Head of Regulatory Affairs International. She gained her Regulatory Science expertise from Public Private Partnerships and as member of several EFPIA teams in regular dialogue with Regulatory Agencies. Isabelle supported the preparedness of Bayer for the HTA Regulation as a member of the EU HTA Task force and has contributed to the policy discussion on the practical implementation of the Regulation at the interface between Regulators, HTAs and HT developers.

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