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Vaccines

Apr 24 - Apr 25, 2018
Malaga, Spain

  • Conference
  • Europe
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Program Highlights

Regulatory Speakers Confirmed!

  • Mats Welin
    Medical Products Agency, Sweden
  • Heidi Meyer, PhD
    Paul-Ehrlich-Institut
  • Gwenaël Ciréfice, PhD
    European Directorate for the Quality of Medicines & HealthCare, EDQM
  • Richard H. Siggers, PhD
    Biologics and Genetic Therapies Directorate, Health Canada
  • Erika Pfeiler, PhD
    CDER Division of Microbiology Assessment, US FDA
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Overview

Dear Colleagues,

We are delighted to invite you to the 2018 PDA Europe Vaccines conference to be held 24-25 April 2018.

The conference will address new trends in vaccine development and life cycle management, including (1) use of platform technologies, (2) prior knowledge, (3) development of novel vaccines comprising therapeutic vaccines and cancer vaccines, and (4) considerations on accelerated development scenarios. In this context, Quality by Design principles have now been embedded in various aspects of vaccine development and beyond. The conference will provide an overview of the applicability of QbD in various aspects, from product, analytics and process standpoint and considerations during life cycle management, as well as touch base on newer trends in the regulatory field such as ICHQ12.

We aim to continue the discussion around current CMC trends and regulatory strategies for emerging diseases, as started in frame of the Ebola vaccine some years ago and which has evolved since then.

We look forward to welcoming you to this special PDA Europe event in Spain next April!

Sincerely, The Chairs

Cristiana Campa, Conference Chair, GSK Vaccines
Nancy Cauwenberghs, Conference Chair, MSD

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Agenda

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  • Tuesday, 24 April 2018

    9:00
    Welcome and Introduction
    Kerstin Wilken, PDA Europe
    Cristiana Campa, Conference Chair, GSK Vaccines
    Nancy Cauwenberghs,Conference Chair, MSD

    9:10 - 11:15
    Session 1: Regulatory Updates
    Moderator: Thierry Gastineau, Sanofi

    9:10
    Regulatory Convergence for Vaccines & Post Approval Changes
    Heidi Meyer, Paul-Ehrlich-Institut

    09:40
    Harmonized Approaches for Vaccine Lifecycle Management
    Richard H. Siggers, Biologics and Genetic Therapies Directorate, Health Canada

    10:10
    Human Vaccines in the European Pharmacopoeia: Latest Developments
    Gwenaël Ciréfice, European Directorate for the Quality of Medicines & HealthCare, EDQM

    10:40
    Q&A, Discussion

    11:15 – 11:45
    Coffee Break, Poster Session & Exhibition

    11:45 - 13:30
    Session 2: Platform Technologies & New Products
    Moderator: Kerstin Wilken, PDA Europe

    11:45
    A New TB Vaccine on the Horizon
    Leander Grode, VPM

    12:10
    Next Generation of Glycan-based Vaccines
    Arne v. Bonin, Vaxxilion

    12:35
    Use of Platform and Prior Knowledge to Advance Development of Adenoviral Vector-based Vaccines
    Els van Deventer-Troost, Janssen J&J

    13:00
    Development and Optimization of Viral Platform Manufacturing Processes for Cost Effective and Faster Release of Vaccines
    Anissa Boumlic, Merck KGaA

    13:30 – 14:30
    Lunch Break, Poster Session & Exhibition

    14:30 – 16:30
    Session 3: Accelerated Development and Prior Knowledge
    Moderator: Nancy Cauwenberghs, MSD

    14:30
    Prior Knowledge - Considerations for Vaccines
    Mats Welin, MPA

    15:00
    Acceleration Strategies for Fast Access of Vaccines to Patients
    Amin Khan, GSK Vaccines

    15:30
    A Vaccine for Ebola Virus - A Case Study on Approaches to Accelerate Process Development and Characterization Studies
    Joseph P. Califano, MSD

    16:00
    Q&A, Discussion

    16:30 – 17:00
    Coffee Break, Poster Session & Exhibition

    17:00 – 18:30
    Session 4: Risk-based Approaches to Analytical Development and Facility Design for Vaccines
    Moderator: Annick Vandercammen, GSK Vaccines

    17:00
    Application of the QbD Mindset to the Analytical Strategy - The Key to Success
    Thomas Jacques, GSK Vaccines

    17:30
    Challenges and Opportunities of QbD Integration in Vaccine Development and Manufacturing
    Nausheen Rahman, Sanofi Pasteur

    18:00
    Risk-Based Biopharmaceutical Facility Design Approaches
    Kavita Ramalingam Iyer, MSD

    18:30
    End of Conference Day 1

    19:30
    Networking Reception

    Wednesday, 25 April 2018

    9:00
    Welcome and Introduction
    Kerstin Wilken, PDA Europe
    Cristiana Campa, Conference Chair, GSK Vaccines
    Nancy Cauwenberghs,Conference Chair, MSD

    9:05 - 11:05 
    Session 5: Evolving Technical Considerations for Vaccine Manufacturing
    Moderator: Cristiana Campa, GSK Vaccines

    9:05
    Predicting Pyrogenic Content without Animal Models
    Sara Valentini, GSK

    9:35
    The Challenge of Process Parameters Categorization: A Comprehensive Ranking Process
    Geoffroy Geldhof, GSK Vaccines

    10:05
    Process Validation and Continuous Process Verification of the Sterilization Process of Vaccines
    Anton Mangold, tempris
    Alexandre Cassis, GSK Canada

    10:35
    Pre-fillable Syringe Selection Criteria for Vaccines: Technical Comparison of Several Syringe Types
    Laurent Jeanmart, GSK Vaccines
    Christian Helbig, SCHOTT

    11:05 – 11:35
    Coffee Break, Poster Session & Exhibition

    11:35 – 13:15
    Session 6: Innovative Downstream Processing for Vaccines
    Moderator: Martha Folmsbee, PALL

    11:40
    Filtering Confusion from the Review Process: Current Topics in Sterilizing Filtration at FDA/CDER
    Erika Pfeiler, US FDA

    12:05
    Understanding the Sterile Filtration of Vaccine Nanosuspensions
    John Welsh, PALL

    12:35
    Filter-based Clarification of Viral Vaccines & Vectors
    Youness Cherradi, Merck KGaA

    13:00
    Q&A, Discussion

    13:15 – 14:15
    Lunch Break, Poster Session & Exhibition

    14:15 – 17:00
    Session 7: Global Industry Perspectives on Current Regulation - Future Outlook
    Moderator: Nancy Cauwenberghs, MSD

    14:15
    The Complexity of Post-Approval Change Management and New Regulatory Approaches: Relevance for Vaccine Products
    Andrew Deavin, GSK Vaccines
    Thierry Gastineau, Sanofi Pasteur

    14:45
    Vaccine Shortage - From Words to Action Vaccines Heads of Quality Perspective
    Anders Vinther, Sanofi Pasteur
    Marcello Colao, GSK Vaccines

    15:15 – 15:45
    Coffee Break, Poster Session & Exhibition

    15:45
    Panel Discussion, Q & A - Conference Highlights: Opportunities for Vaccine Development
    Mats Welin, MPA
    Heidi Meyer, PEI
    Richard H. Siggers, Health Canada
    Gwenaël Ciréfice, EDQM

    16:30
    Summary & End of Conference & Farewell
    Cristiana Campa, Conference Chair, GSK Vaccines
    Nancy Cauwenberghs, Conference Chair, MSD
    Kerstin Wilken, PDA Europe

Additional Information

  • Call for Abstracts

    Download Call for Papers

    Call for Papers/Abstracts is available now.

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    Abstract Submission

    Call for Papers/Abstracts is available now.

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  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    Who Should Attend

    More information coming soon.

  • Accreditation

    Accreditation

    Continuing Education for Pharmacists

    ACPE PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:


    Type of Activity:

    ALERT   ACPE and NABP developed the CPE Monitor that allows pharmacists to electronically track their continuing pharmacy education (CPE) credits. The CPE Monitor will reject any CPE credit requests submitted past 60 days from date of ACPE-accredited activity. Always submit CPE activity claims as soon as possible. For more information, please visit the ACPE or NABP website.

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