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Wednesday, Sep 18th
9:15 AM – 10:30 AM PDT
Health Authority Forum: Europe Forum, European Medicines Agency (EMA) & European Regulatory Network
Location/Room: 104 A
Presenter: Sabine Haubenreisser, MSc, PhD – European Medicines Agency
Presenter: Andrea Laslop, MD – Austrian Medicines and Medical Devices Agency
Presenter: Anabela Marcal – European Medicines Agency
Presenter (Remote): Caroline Pothet – European Medicines Agency
Health Authority Session
Wednesday, Sep 18th
1:00 PM – 2:00 PM PDT
Conversations That Matter - Interactions With Health Authorities: Medical Devices and IVDs
Location/Room: 104 A
Moderator: Jethro Ekuta, DVM, PhD, RAC, FRAPS – Alexion, AstraZeneca Rare Disease
Panelist: Judith Arcidiacono, MS – US Food and Drug Administration
Panelist: Suzanne Halliday, PhD – BSI
Panelist: Sabine Haubenreisser, MSc, PhD – European Medicines Agency
Panelist: Sabina Hoekstra, PharmD FRAPS – TÜV SÜD Medical Health Services
Panelist: Andrea Laslop, MD – Austrian Medicines and Medical Devices Agency
Health Authority Session
Wednesday, Sep 18th
2:15 PM – 3:15 PM PDT
Health Authority Forum: CDRH - FDA's Center for Devices and Radiological Health
Location/Room: 102
Presenter (Remote): Michelle Tarver, MD, PhD – U.S. Food and Drug Administration/ CDRH
Presenter (Remote): Felipe Aguel – FDA CDRH
Presenter (Remote): Angela Krueger – US Food and Drug Administration
Presenter (Remote): April Marrone
Panel Facilitator: Megha Iyer, MSc, MS, RAC, FRAPS – Thermo Fisher Scientific
Health Authority Session
Thursday, Sep 19th
9:15 AM – 10:30 AM PDT
Conversations That Matter - Interactions With Health Authorities: Drugs, Biologics and Combination Products
Location/Room: 104 A
Moderator: Jethro Ekuta, DVM, PhD, RAC, FRAPS – Alexion, AstraZeneca Rare Disease
Panelist (Remote): Peter W. Marks, MD, PhD – United States Food and Drug Administration
Panelist: Sabine Haubenreisser, MSc, PhD – European Medicines Agency
Panelist: Anabela Marcal – European Medicines Agency
Panelist: Tshetsana Senau – Botswana Medicines Regulatory Authority
Health Authority Session
Thursday, Sep 19th
3:15 PM – 4:15 PM PDT
Health Authority Forum: CBER - FDA’s Center for Biologics Evaluation and Research (CBER)
Location/Room: 104 A
Presenter (Remote): Peter W. Marks, MD, PhD – United States Food and Drug Administration
Presenter: Christopher Joneckis, PhD – US FDA
Moderator: Katie Rivers, MS – FDA/CBER/ORO/DROP/RABOB
Panel Facilitator: Tyler C. Vandivort, PhD, RAC, DABT – UCB Biopharma
Health Authority Session
Thursday, Sep 19th
4:30 PM – 5:30 PM PDT
Health Authority Forum: CDER - FDA's Center for Drug Evaluation and Research
Location/Room: 104 A
Presenter (Remote): Peter P. Stein, MD – Office of New Drugs, CDER, FDA
Panel Facilitator: Jewell Martin, MA, MBA, PMP, RAC – BioMarin Pharmaceutical, Inc.
Health Authority Session
Thursday, Sep 19th
4:30 PM – 5:30 PM PDT
International Harmonization & Regulator Forum
Location/Room: 104 C
Moderator: Olga Van Grol-Lawlor, MPHIL – Boston Scientific
Presenter: Jasjit Baveja, PhD – Medical Technology Association of Australia
Presenter: Tshetsana Senau – Botswana Medicines Regulatory Authority
Presenter (Remote): Paulyne Wairimu – Pharmacy and Poisons Board, Kenya
Panelist (Remote): Faiza Alzadjali
Presenter: Stephen Lee – ABHI
Health Authority Session