Agenda

Day 1 Apr 23, 2019

11:30 AM — 5:00 PM

Registration

12:15 PM — 12:30 PM

Welcome and Opening Remarks

12:30 PM — 1:15 PM

Keynote Address

1:15 PM — 2:45 PM

Session 1: Emerging Technologies in Pharmaceutical Manufacturing

2:45 PM — 3:15 PM

Refreshments, Exhibits, and Networking Break

3:15 PM — 4:45 PM

Session 2 Track A: Challenges with Lifecycle Management

3:15 PM — 4:45 PM

Session 2 Track B: Non-Traditional Drug Modalities

3:15 PM — 4:45 PM

Session 2 Track C: Human Factors

4:45 PM — 5:45 PM

Networking and Exhibits Reception

Day 2 Apr 24, 2019

7:00 AM — 8:00 AM

Networking Breakfast in the Exhibit Hall

7:00 AM — 5:00 PM

Registration

8:00 AM — 10:00 AM

Session 3: FDA White Paper on Patient Centric QOS and Current Topics at FDA Including Data Standards and KASA

10:00 AM — 10:30 AM

Refreshments, Exhibits, and Networking Break

10:30 AM — 12:30 PM

Session 4 Track A: Patient-Centric Quality Standards

10:30 AM — 12:30 PM

Session 4 Track B: ICH Q12 Implementation

10:30 AM — 12:30 PM

Session 4 Track C: International Combination Product Regulation

12:30 PM — 1:30 PM

Networking Luncheon in the Exhibit Hall

1:30 PM — 3:00 PM

Session 5 Track A: Accelerated Development – CMC Challenges and Best Practices

1:30 PM — 3:00 PM

Session 5 Track B: Opportunities and Challenges for Developing ATMP Products

1:30 PM — 3:00 PM

Session 5 Track C: Combination Products CMC

3:00 PM — 3:30 PM

Refreshments, Exhibits, and Networking Break

3:30 PM — 5:00 PM

Session 6 - Quality Metrics - QM Feedback Program, 2018 QM Site Visit Program

Day 3 Apr 25, 2019

7:00 AM — 8:00 AM

Networking Breakfast in the Exhibit Hall

7:00 AM — 4:15 PM

Registration

8:00 AM — 10:00 AM

Session 7 Track A: Revision of ICHQ2 and ICHQ14: Analytical Procedure Development

8:00 AM — 10:00 AM

Session 7 Track B: Q13 Continuous Manufacturing

10:00 AM — 10:30 AM

Networking Break in the Exhibit Hall

10:30 AM — 12:00 PM

Session 8 Track A: QbD Incorporation in Large Molecule Development and Regulatory Filings

10:30 AM — 12:00 PM

Session 8 Track B: MRA Implementation: Implementation of the EU-FDA GMP Mutual Recognition Agreement (MRA): FDA Update and Industry Survey Results

10:30 AM — 12:00 PM

Session 8 Track C: Essential Performance Requirements

12:00 PM — 1:00 PM

Networking Luncheon in the Exhibit Hall

1:00 PM — 2:30 PM

Session 9 Track A: International CMC Topic

1:00 PM — 2:30 PM

Session 9 Track C: Combination Product GMPs

2:30 PM — 3:00 PM

Refreshment, Exhibits, and Networking Break

3:00 PM — 4:00 PM

Session 10: Q12 Updates

4:00 PM — 4:15 PM

Closing Remarks

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