The strategic considerations to successfully navigate the regulatory complexities of targeted medicines

Medicon Valley Alliance and PharmaLex are pleased to invite you to a Good Morning Meeting on the 7th of June in Copenhagen focusing on:

The strategic considerations to successfully navigate the regulatory complexities of targeted medicines.

Clinically developing targeted therapies is considered a complex and time-consuming process, requiring a deep understanding of disease biology and the molecular mechanisms driving disease. But the complexities go far beyond the science.

Targeted medicines present a cutting-edge paradigm of treating disease – one in which selected patients benefit through a potentially longer and better quality of life. But to truly realize the great potential these therapies offer to patients, we need a concerted effort to share knowledge and experience across drug and diagnostic developers, regulatory authorities, patient advocacy groups, stakeholders, and the extended partner community.

Join us as we share insights on where targeted medicines are headed and how organizations should plan to navigate new and emerging regulations and the unique aspects of these therapies that require a holistic strategy.

Topics will include:

  •  Ways organizations can mitigate clinical risks early in the development process.
  • Navigating regulatory frameworks while addressing regulatory concerns about safety, efficacy, and quality.
  • Opportunities to partner with regulatory authorities to incorporate their knowledge and experience into development efforts.

Date: Tuesday 7th of June 2024
Time: 8:30 – 11:00
Venue: Medicon Valley Alliance, Arne Jacobsens Allé 15, 2300 Copenhagen S, Denmark – Meeting room: Auditorium

REGISTER NOW

 

Program

8:30 Networking, registration and light breakfast
9:00 Welcome and introduction to Medicon Valley Alliance
David Munis Zepernick, Director, Member Engagement & Communication, Medicon Valley Alliance
9:05 Company introduction, PharmaLex (becoming Cencora)
Torben Thers Norgaard, Head, Nordic region, PharmaLex
 9:15 Mastering the complexities of targeted medicines
Christian K Schneider, Vice President and Chief Medical Officer, Strategic Product Development Consulting, PharmaLex
10:00 Q&A Session
10:15 Networking
11:00 End of Good Morning Meeting

Christian K Schneider, Vice President and Chief Medical Officer, Strategic Product Development Consulting, PharmaLex

Dr. Christian K Schneider has a long professional history with biologicals, including monoclonal antibodies and advanced therapies. Before joining PharmaLex, Christian was interim Chief Scientific Officer at the UK’s medical products regulator, the Medicines and Healthcare products Regulatory Agency (MHRA). Before that, he was Director of the National Institute for Biological Standards and Control (NIBSC), an agency within the MHRA. He was Medical Head of Division Medicines Licensing & Availability at the Danish Medicines Agency, and Head of Division EU Cooperation/Microbiology at the Paul-Ehrlich-Institute, Germany’s Federal Agency for Vaccines and Biomedicines. Christian has also held various senior delegate roles at the European Medicines Agency (EMA), including as Chair of the EMA’s Committee for Advanced Therapies (CAT) and member of the EMA’s Committee for Medicinal Products for Human Use (CHMP). As a regulatory scientist, he has published more than 50 articles in international peer-reviewed journals.

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