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Wednesday, Oct 8th
9:15 AM - 10:30 AM EST
Health Authority Forum: Europe Forum, European Medicines Agency (EMA) & European Regulatory Network
Location/Room: Spirit of Pittsburgh Ballroom, Level 3
Presenter: Sabine Haubenreisser, MSc, PhD, FRAPS – European Medicines Agency
Presenter: Corinne S. de Vries, MA MSc PhD FISPE – European Medicines Agency
Presenter: Alberto Ganan, PhD – European Medicines Agency
Presenter: Andrea Laslop, MD – Malta Medicines Authority
Health Authority
Wednesday, Oct 8th
2:15 PM - 3:15 PM EST
International Regulators Forum
Location/Room: Spirit of Pittsburgh Ballroom, Level 3
Moderator: Bassil Akra, PhD – AKRA TEAM
Speaker: John Borg, Prof, PhD, Technical Director, Medicines Authority Malta – Malta Medicines Authority
Speaker: Kimberly A. Trautman, MS – RAPS BoD
Health Authority
Wednesday, Oct 8th
4:30 PM - 5:30 PM EST
Conversations That Matter - Interactions With Health Authorities: Medical Devices and IVDs
Location/Room: Spirit of Pittsburgh Ballroom, Level 3
Moderator: Jethro E. Ekuta, DVM, PhD, EMBA, RAC, FRAPS – Ascendis Pharma, Inc.
Moderator: Susan Stewart, JD, LLM, RAC, FRAPS – Rezolute Bio
Panelist: Alberto Ganan, PhD – European Medicines Agency
Panelist: Sabina L. Hoekstra, PharmD FRAPS – TUV SUD
Panelist: Tom Patten, n/a – GMED
Panelist: Marta Carnielli, n/a – TUV Sud Product Service GmbH
Panelist: Suzanne Halliday, DPhil, FRAPS – BSI
Panelist: Donal O'Connor, MD FEBS – HPRA
Panelist: Kimberly A. Trautman, MS – RAPS BoD
Health Authority
Thursday, Oct 9th
9:15 AM - 10:30 AM EST
CANCELLED: Health Authority Forum: CDER - FDA's Center for Drug Evaluation and Research
Location/Room: Spirit of Pittsburgh Ballroom, Level 3
Presenter (Remote): George Tidmarsh – U.S. Food and Drug Administration (FDA)
Health Authority
Thursday, Oct 9th
1:00 PM - 2:00 PM EST
Conversations That Matter - Interactions With Health Authorities: Drugs, Biologics and Combination Products
Location/Room: Spirit of Pittsburgh Ballroom, Level 3
Moderator: Jethro E. Ekuta, DVM, PhD, EMBA, RAC, FRAPS – Ascendis Pharma, Inc.
Moderator: Susan Stewart, JD, LLM, RAC, FRAPS – Rezolute Bio
Panelist: Sabine Haubenreisser, MSc, PhD, FRAPS – European Medicines Agency
Panelist: Corinne S. de Vries, MA MSc PhD FISPE – European Medicines Agency
Panelist: Andrea Laslop, MD – Malta Medicines Authority
Panelist: Kimberly A. Trautman, MS – RAPS BoD
Presenter: Karl-Heinz Huemer, PhD MD – khhconsult
Health Authority