Uwe Gudat (Moderator)

Head of Medical Affairs & CSPV - Fresenius Kabi

Uwe Gudat joined the pharmaceutical industry in 1995 with Eli Lilly and since then has held positions at Hesperion/Actelion, Novartis, Merck Serono and Fresenius-Kabi. He has led global clinical development teams, served as global medical brand director, provided clinical support to global in-licensing teams, conducted formal clinical trial design reviews, performed product safety assessments, and guided first in man transitions. Most recently he was Head of Safety, Biosimilars at Merck KGaA, then in Fresenius-Kabi after their acquisition of the biosimilars unit. In 2022 he will join a start-up providing clinical research education.

Sessions

Tuesday - November 23, 2021 - 10:20

Chairperson’s opening remarks

Tuesday - November 23, 2021 - 14:50

What does a signal, signal?

Tuesday - November 23, 2021 - 15:20

Fireside Chat: Strengthening Risk Evaluation and Mitigation Strategies (REMS)
- Creating a REMS Industry-Wide Standardized Risk Evaluation and Mitigation Strategy (REMS) Program
- Global regulatory developments
- EU GVP XVI revision – what we could expect?
- REMS for generics
- Effective tools and strategies to improve REMS effectiveness
- REMS at the patient-level: improving safety and proper use of medicines
- Evolving REMS: New opportunities for branded drugs
- What have we learned? Next steps toward the future

Tuesday - November 23, 2021 - 17:00

Panel discussion: PV Outsourcing: Challenges and Opportunities
- Building partnerships
- Identifying the key areas for outsourcing
- The main challenges faced and impact of new legislation
- Economy
- PV Quality assurance
- Post-authorization safety studies
- Core competencies, activities-database, follow-up studies, case-studies, etc.