Agenda

Day 1 Jan 21, 2018

9:00 AM — 5:00 PM

Course 1: PBRER

9:00 AM — 5:00 PM

Course 2: Pharmacovigilance and Risk Management Planning

9:00 AM — 12:30 PM

Course 3: Pharmacovigilance Inspections Part 1: Readiness, Conducting, Findings, and Report-Outs

1:30 PM — 5:00 PM

Course 4: Pharmacovigilance Inspections Part 2: Response, Measurement, Resolution, and Tracking

Day 2 Jan 22, 2018

7:15 AM — 8:15 AM

Continental Breakfast, Exhibits, and Networking

7:30 AM — 5:30 PM

Registration

8:15 AM — 8:30 AM

DIA Opening Remarks

8:30 AM — 8:45 AM

Welcome Remarks

8:45 AM — 9:30 AM

Opening Keynote: Patient Advocacy in Rare Disease: Duchenne Muscular Dystrophy

9:30 AM — 11:00 AM

Session 1: FDA Updates

11:00 AM — 11:30 AM

Refreshments, Exhibits, and Networking Break

11:30 AM — 12:30 PM

Session 2: The New ICH

12:30 PM — 2:00 PM

Luncheon and Round Table Discussions

2:00 PM — 3:30 PM

Session 3: Operational Hot Topic: Machine Learning/Artificial Intelligence in Pharmacovigilance

3:30 PM — 4:00 PM

Refreshments, Exhibits, and Networking Break

4:00 PM — 5:30 PM

Session 4: Combination Products

5:30 PM — 6:30 PM

Networking and Exhibits Reception

6:30 PM — 9:00 PM

Dine Arounds

Day 3 Jan 23, 2018

7:30 AM — 8:30 AM

Continental Breakfast, Exhibits, and Networking

7:30 AM — 6:00 PM

Registration

8:30 AM — 8:45 AM

Welcome Remarks

8:45 AM — 9:30 AM

Day Two Keynote: Data Rich, Information Poor – Can We Turn Health Records into a Truly Learning Health Care System?

9:30 AM — 11:00 AM

Session 5: EU Updates

11:00 AM — 11:30 AM

Refreshments, Exhibits, and Networking Break

11:30 AM — 12:45 PM

Session 6: Clinical Trial Issues

12:45 PM — 2:00 PM

Luncheon, Exhibits, and Round Table Discussions

2:00 PM — 2:45 PM

Mid-Day Keynote

2:45 PM — 4:15 PM

Session 7: Update on New Treatments

4:15 PM — 4:45 PM

Refreshments, Exhibits, and Networking Break

4:45 PM — 6:00 PM

Session 8: Advanced Therapeutics Pharmacovigilance and Risk Management

Day 4 Jan 24, 2018

7:00 AM — 8:00 AM

Continental Breakfast, Exhibits, and Networking

7:00 AM — 3:00 PM

Registration

8:00 AM — 8:15 AM

Welcome Remarks

8:15 AM — 9:00 AM

Day Three Keynote: Innovative Pharmacovigilance when Resources are Scarce

9:00 AM — 10:00 AM

Session 9: Advanced Technologies

10:00 AM — 10:45 AM

Refreshments, Exhibits, and Networking Break

10:45 AM — 12:15 PM

Session 10: Regional Updates

12:15 PM — 12:30 PM

Q&A

12:30 PM — 1:45 PM

Luncheon, Exhibits, and Networking

1:45 PM — 3:15 PM

Session 11: Hot Topics

3:15 PM — 3:30 PM

Closing Remarks

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Pharmacovigilance and Risk Management Strategies Conference

Agenda

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