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2018 Pharmacovigilance CoE

APEC RHSC Center of Excellence Pilot Training
on Multi-Regional Clinical Trials and Good Clinical Practice


April 10-13, 2018
Harvard Faculty Club, Cambridge, Massachusetts, United States


Time Topics Speaker
Day 1: Tuesday, April 10, 2018
08:00-08:30 Registration
08:30-09:00 Welcome and Introductions Barbara Bierer (MRCT Center)
Sunhee Lee (AHC)
Session 1: Basics of MRCT & Development Strategy
09:00-11:00 How ta regulatory decision is made Yoko Aoi (PMDA)
Expectations, Current Issues, Regulatory Requirements for MRCT development

Yuki Ando (PMDA)
Karen Weiss (Johnson & Johnson)
11:00-11:15 Break
11:00-13:15 Evolution of MRCT Guidance in Global Clinical Drug Development Robert O’Neil (US FDA)
Essential Information for MRCT Carole Legare (Health Canada)
Relevant ICH Guidelines for MRCT, Overview

Carole Legare (Health Canada)
13:15-14:15 Lunch
Session 2: Protocol Design and Statistical Analysis
14:15-15:45 General Principles for Planning and Design of Multi-Regional Clinical Trials - ICH E17 Aloka Charkravarty (US FDA)
15:45-16:00 Break
16:00-17:00 Multi-Regional Clinical Trial Case Study: PLATO study on Ticagrelor Aloka Charkravarty (US FDA)
17:15-18:15 Walking Tour of Harvard University
18:30-19:30 Reception
Time Topics Speaker
Day 2: Wednesday, April 11, 2018
08:00-08:30 Registration
Session 3: Selection of doses for MRCT - Finding the optimal dosage
08:30-10:30 Finding the optimal dosage Honghui Zhou (Johnson & Johnson)
Respondent: Robert O’Neil (US FDA)
10:30-10:45 Break
Session 4: Handling of Adverse Drug Reaction Report
10:45-12:45 Handling of Adverse Drug Reaction Report Carole Legare (Health Canada)
Adverse Drug Reaction (ADR) reports: An Investigator’s Perspective Barbara Bierer (MRCT Center)
12:45-13:45 Lunch
13:45-14:45 Transfer to Takeda
Session 5: Clinical Data Analysis
14:15-16:15 Clinical Data Analysis Steven Snapinn (Amgen)
16:15-16:30 Break
16:30-17:30 Takeda Introduction and Presentation, with Q & A
17:30-19:30 Tour of Takeda and Reception
Time Topics Speaker
Day 3: Thursday, April 12, 2018
08:00-08:30 Registration
Session 6: Post-Approval Risk Management Plan
08:30-10:30 Post-Approval Risk Management Plan - Industry perspective Jennifer Reinert (Pfizer)
Post-Approval Risk Management Plan - Regulatory perspective Carole Legare (Health Canada)
10:30-10:45 Break
Session 7: Assessment of Mock Marketing Authorization Application
10:45-12:45 Assessment of Marketing Authorization Application Jerry Stewart (PhRMA)
Yuki Ando (PMDA)
12:45-13:45 Lunch
13:45-14:15 Q&A session with Regulators Moderator: Barbara Bierer (MRCT Center)
Session 8: GCP inspection in the Review of MRCT data
14:15-15:30 Guideline on Good Clinical Practice ICH E6(R2) Sinead Curran (IHPRA)
15:30-15:45 Break
15:45-16:45 Real World GCP Inspection Ni Khin (US FDA)
Time Topics Speaker
Day 4: Friday, April 13, 2018
08:00-08:30 Registration
08:30-11:30 Mock Dossier Workshop GCP/Case Studies & Site selection for Inspection & Data Management Ni Khin (US FDA)
GCP E6(R2) in Practice Workshop Sinead Curran (IHPRA)
11:30-11:45 Break
11:45-12:15 “Ask the Experts” - Q&A session Moderator: Barbara Bierer (MRCT Center)
12:15-13:00 Post-Course Evaluation, Participation Certificates, Closing Barbara Bierer (MRCT Center)