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2021 Current and Future Trends in Vaccines

2021 PDA Current and Future Trends in Vaccines Workshop

Nov 09 - Nov 10, 2021
Eastern Standard Time | Online
  • Virtual
  • Online

Overview

On behalf of the Program Planning Committee and PDA, we would like to invite you to participate in the 2021 PDA Current and Future Trends in Vaccines Workshop on 09-10 November 2021. The agenda for this virtual workshop will focus on two areas of high interest to the Vaccine Industry (1) Vaccine Lifecycle Management and (2) New Modalities for Vaccines.

Day 1 of the workshop will focus on Vaccine Lifecycle Management. Presentations will include (a) an overview of soon to be released PDA Vaccine Technical Report; (b) Lessons Learned from COVID-19 pandemic on Vaccine Lifecycle Management; (c) Improvements to Vaccine Lifecycle Management with implementation of ICH Q12; and (d) case studies on identification of Established Conditions (EC’s) and how to justify and report them.

Day 2 of the workshop will focus on New Modalities. Presentations will include (a) an overview discussion of Novel Modalities vs Traditional Vaccines; (b) Different approaches to mRNA vaccines (success and globalization); and (c) Regulatory perspectives of Novel Vaccine submissions by FDA.

The workshop has been designed specifically to provide opportunities for direct involvement of the participants with the speakers in working groups discussion, Q&A, and development of publication of the workshop output covering the 2 main areas of the workshops focus.

We look forward to your participation in the virtual 2021 PDA Current and Future Trends in Vaccines Workshop on 09-10 November.

Agenda

  • Day 1
  • Day 2
  • TUESDAY, 09 NOVEMBER

    10:00 – 11:15 | Plenary 1: Vaccine Lifecycle Management
    Moderator: Jane Halpern, Consultant

    10:00 | Welcome and Overview from Co-Chairs
    Andrew Chang, Novo Nordisk
    Earl Zablackis, Sanofi

    10:15 | Overview of Vaccine Technical Report
    Sabrina Restrepo, Merck

    10:30 | Lessons Learned from COVID-19 Pandemic on Vaccine Lifecycle Management
    Thierry Gastineau, Sanofi

    10:45 | Improve Product Lifecycle Management for Efficiency and Predictability: How Could ICH Q12 Guideline Help?
    Andrew Chang, Novo Nordisk

    11:00 | Vaccine Case Studies: Identification of Established Conditions (ECs) and Justification for Reporting Categories When Make Change of The ECs
    Earl Zablackis, Sanofi

    11:15 – 11:25 | Break

    11:25 – 12:20 | Small Group Work

    Attendees will work in either Group1: Established Conditions and PQS or Group 2: Vaccine/Product Lifecycle Management Plan

    11:25 | Overview

    11:35 | Working Groups

    12:20 – 12:30 | Break

    12:30 – 13:15 | Report Out

    12:30 | Group 1 Report Out

    12:40 | Group 2 Report Out

    12:50 | Panel Discussion and Q&A

    13:10 | Closing Remarks from Co-Chairs
  • WEDNESDAY, 10 NOVEMBER

    10:00 – 11:15 | Plenary 2: New Modalities for Vaccines
    Moderator: Stephan O. Krause, PhD, Director of Product Quality, AstraZeneca

    10:00 | Welcome and Remarks from Co-Chairs
    Andrew Chang, Novo Nordisk
    Earl Zablackis, Sanofi

    10:15 | Traditional Vaccines vs. Novel Modalities
    Industry Speaker Invited

    10:35 | Different Approaches to mRNA Vaccines
    Industry Speaker Invited

    10:55 | Regulatory Perspective on New Modalities for Vaccines
    CBER, U.S. FDA Speaker Invited

    11:15 – 11:25 | Break

    11:25 – 12:20 | Small Group Work

    Attendees will work in either Group1: New Modalities or Group 2: Manufacturing Challenges

    11:25 | Overview

    11:35 | Working Groups

    12:20 – 12:30 | Break

    12:30 – 13:15 | Report Out

    12:30 | Group 1 Report Out

    12:40 | Group 2 Report Out

    12:50 | Panel Discussion and Q&A

    13:10 | Closing Remarks from Co-Chairs

Registration Fees

Register Now
Early Registration
Registration Type Price by 30 Sept 2021
Member $598
Non-Member $738
Govern./Health Authority/Academic Member $280
Govern./Health Authority/Academic Non-member $320
Student Member $112
Student Non-member $124
Young Professional Member $299
Regular Registration
Registration Type Regular Registration Price after 1 Nov 2021
Member $837 $1,076
Non-Member $1,033 $1,328
Govern./Health Authority/Academic Member $392 $504
Govern./Health Authority/Academic Non-member $448 $576
Student Member $157 $202
Student Non-member $174 $223
Young Professional Member $419 $538

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