Symposium 2023 | Collections | Regulatory Rapporteur

DECEMBER 2023 | VOL. 20 | NO.11

TOPRA Annual lecture
By Julien Douillet
HM1: Update on EU new regulatory legislation − EMA, industry and others
By Frédéric Pailloux
HM2: Improving the odds of regulatory success
By Celine Combet
HM3: A spotlight onto the future – fireside chat
By Margarida Morgado
HM4: The evolving clinical trial landscape
By Carla Gomes
HM5/MD1/IVD1: Process for regulations and implications of different legislation – how to follow and decide which regulation will impact your product development
By Joan Boren
HM6: Real-world evidence and the use of big data for regulatory decision making; DARWIN EU
By Margarida Morgado
HM7: Paediatric investigational plans
By David Uguen
HM8: Regulatory mechanisms to expedite drug development and patient access (e.g. PRIME)
By Margarida Morgado
HM9: Patient engagement in the regulatory lifecycle of medicines
By Margarida Morgado
MD2/IVD2:
Medical technologies −
a catalyst for
regulatory innovations
By Celia Cruz
MD3: Navigating the regulatory maze: challenges of medical device software
By Celia Cruz
MD4: Challenges and opportunities for small companies and start-ups
By Celia Cruz
MD5: Post-market challenges
By Mehryar Behizad
IVD3: IVDR: Current state
By Mehryar Behizad
IVD4: How to manage diverging regulatory strategies within a global market (China, US and the EU)
By Ashleigh Batchen
IVD5: Class D IVDs
By Hasnaa Fatehi
PS1:
Health technology assessment –
the new EU regulation
By Maria Nieto-Gutierrez
PS2: ATMP innovations and clinical trials with genetically modified organisms
By Davina Stevenson
VM1:
Horizontal legislation and
veterinary medicine availability
By Rick Clayton
VM2: New initiatives in regulatory science
By Rhona Banks
VM3: Regulatory exchange and new/future approaches
By Mel Munro
VM4: Living with post-authorisation obligations – progress, challenges and future opportunities
By Anja Holm
VM5: Digital innovation to support animal health
By Kornelia Grein