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2020 Quality Regulations

PDA Europe Virtual Conference - Quality and Regulations

Jun 09 - Jun 11, 2020
9:00 AM
-
5:00 PM
| Central Europe Standard Time
Online
  • Conference
  • Virtual
  • Europe
  • Online

Overview

SCIENTIFIC PROGRAM PLANNING COMMITTEE

Barbara Allen, Eli Lilly, Chair
Frank Hallinan, former IMBChair
Vinny Browning III, Amgen
Karin Baer, Boehringer Ingelheim
Karen Casey, Janssen J&J
Graham Cook, Pfizer
Patrick Costello, Abbvie
Anne Hayes, HPRA, PIC/S
Toni Manzano
, Bigfinite
Ruth Miller, PDA
Peter Reichert, Zelect
Falk Klar, PDA Europe
Sylvia Becker, Senior Manager Programs & Events, PDA Europe

Agenda

  • Day 1
  • Day 2
  • Day 3
  • Tuesday, 09 June 2020

    Module I: Welcome & Regulatory Updates
    10:30-12:45 CEST

    This decade will see unprecedented change in the number of new type of medicines and the technology and data tools to manufacture them. In addition, reliable supply of quality medicines in a global environment will continue to be core to the industry. In this session, industry and regulatory leaders will share their insights on the key anticipated changes and how quality assurance and regulatory focus will move with them. Subsequent sessions will explore the themes raised and experts will share relevant experiences and ideas.
    Welcome and Opening Remarks Falk Klar, PhD, PDA Europe
    Welcome from the PDA President Richard Johnson, PDA
    Welcome from PDA Board of Directors Chair Jette Christensen, BoD

    Program Preview: What's Planned for the next Days

    Conference Chairs
    Barbara Allen, PhD, Eli Lilly
    Prof. Frank Hallinan, PhD, Consultant

    Regulatory Updates

    Moderator:
    Barbara Allen, Eli Lilly

    HPRA & EMA Strategy 2020 – 2025 Lorraine Nolan, CEO of HPRA
    Manufacturing in a New Decade and What it Means for Regulations & Quality Anil Sawant, Merck Sharp Dohme, Senior Vice President, Global Quality Compliance
    Quality Culture – The Pathway to the Future Anthony Morandi, AstraZeneca, Vice President of Corporate Quality & Strategy

    Live Q & A, Discussion

     

    Break and Virtual Exhibition
    12:45-14:15 CEST

     

    Module II: Quality Risk Management & Knowledge Management
    14:15-17:00 CEST

    QRM has been an integral enabling element of the pharmaceutical quality system (PQS) since the adoption of ICH Q9. Despite it now being widely used, many uncertainties remain regarding QRM, for example, formal vs informal, enabler or, QS tool. This session will examine QRM in its role of an enabler of the PQS as outlined in ICH Q10. This will include the perspective of an experienced regulator with a long standing interest in QRM bolstered by multiple publications on the topic and from an industry expert who also is author of important publications on the topic. We anticipate that attendees at the session will leave with a deeper understanding of how QRM is most appropriately and effectively used within their organization’s Quality System.

    Q10-Enablers: Quality Risk Management & Knowledge Management

    Moderator:
    Frank Hallinan, Consultant

    A Regulator's Perspective on Quality Risk Management & Knowledge Management after 12 Years Kevin O'Donnell, HPRA
    An Industry Perspective on How Quality Risk Management Does and Will Enable an Effective Pharmaceutical Quality System Ghada Haddad, Merck Sharp Dohme
    A Framework for Realization of Knowledge Management as a PQS Enabler Marty Lipa, Technological University Dublin
    How Does Knowledge Management Enable a PQS and How Management Review Supports It Michele Simone, Bracco
    N-nitrosamine Impurities: Actions, Lessons Learned and Next Steps Oliver Meier, Novartis

    Live Q & A, Discussion

     

    Virtual Networking Event
    17:00-18:00 CEST

    Meet your peers in one of our group chats

  • Chatroom I: Exchange Forum for Best Practice during COVID_19
  • Chatroom II: Delve Deeper into the Hot Topics of Today's Discussions
  • Chatroom III: Share Your Craziest Experience and Newly Discovered Hobbies during COVID_19 Lockdown
  • Exchange Forum: Meet the Regulator
  •  

  • Wednesday, 10 June 2020

    Module III: Digital Solutions & Quality
    10:00-12:10 CEST

    The complexity associated with manufacturing of biopharmaceuticals has increased because of the intrinsic variability of the materials and interconnected processes involved. Control of these multivariate operations requires to be managed under a quality approach supported by technology and modern systems that adequately manage to cope with this reality. This session will share and discuss experiences implementing quality from new perspectives.

    Digital Solutions & Quality

    Moderator:
    Toni Manzano, BigFinite

    Continued Process Verification (CPV) of the Future:
    Better Understanding of the Upstream Process

    Francisco Valero,
    Universitat Autonoma de Barcelona

    Digital Change Implementation in the Context of CMC Transformation

    David O'Grady,
    Sanofi

    Data Integrity – Mission Unaccomplished

    Siegfried Schmitt,
    Parexel

    Leveraging Modern Technologies:
    Improving Overall Product Quality and Meeting Regulatory Compliance - Case Study

    Robert Gaertner,
    Veeva

    Live Q & A, Discussion

     

    Break and Virtual Exhibition
    12:10-14:00 CEST

     

    Module IV: Regulatory Oversight
    14:00-16:45 CEST

    Regulatory oversight is an integral part of quality assurance. This session will look at the evolution of inspections, pharmacopeia and compliance.

    Regulatory Oversight

    Moderator:
    Patrick Costello, AbbVie

    Irish Regulatory Perspective on Inspections

    Paul Sexton,
    HPRA

    The Evolving Regulatory Environment:
    PIC/S - Where We Are and Where We Move To

    Anne Hayes,
    PIC/S

    The Evolution of Compliance and Cost of Quality

    Rick L. Friedman,
    US FDA

    Updates on Monographs and Chapters & Recent Developments in Biologics

    Maura Kibbey,
    United States Pharmacopeia

    European Updates for the New Decade

    Cathie Vielle,
    European Directorate for the Quality of
    Medicines & HealthCare

    Live Q & A, Discussion

     

    Virtual Networking Event
    16:45-17:30 CEST

    Meet your peers in our open chat

  • Thursday, 11 June 2020

    Module V: Life Cycle Management and Change Management
    10:00-12:30 CEST

    Ensuring continued quality and supply requires updates and changes. This session will explore how change management will evolve over the coming decade.

    Life Cycle Management and Change Management

    Moderator:
    Graham Cook, Pfizer

    Control Strategies:
    A Foundation for Quality and Regulatory Flexibility

    David Churchward,
    MHRA

    ICH Q12 Implementation from a
    Chemistry, Manufacturing and Controls Perspective

    Mihai Bilanin,
    GSK

    Demonstrating Effectiveness of PQS for PAC

    Emma Ramnarine,
    Roche/Genentech

    What is Data Integrity in a QMS

    Travis Frick,
    GSK

    PDA Tech Report 65 on Tech Transfer

    Beth J. Haas,
    CAI

    Live Q & A, Discussion

     

    Break and Virtual Exhibition
    12:30-14:00 CEST

     

    Module VI: Global Quality Assurance In The New Decade
    14:00-16:30 CEST

    The assurance of quality is based on robust control strategy and an effective quality management system, supported by regulatory authority oversight. In this session, Industry and regulatory authority leaders will share how assurance continues to evolve, based on learning from events and from proactive planning.

    Global Quality Assurance In The New Decade

    Moderator:
    Karin Baer, Boehringer-Ingelheim

    The Global Supply Chain and US Regulatory Trends

    Ashley B. Boam,
    US FDA

    An Industry Approach to Drug Shortage Prevention

    Stephan Roenninger,
    Amgen

    Managing the Digitalization:
    Demonstrate how the PQS is Contributing to this Transformation Process

    Padraig Landers,
    Bristol-Myers Squibb

    Quality: Pathway to the Future

    Anders Vinther,
    Intarcia Therapeutics

    Live Q & A, Discussion

    Conference Summary

    Conference Chairs,
    Barbara Allen, Eli Lilly,
    Frank Hallinan, Consultant

    Chair Awards, Closing Remarks and Farewell

    Falk Klar, PDA Europe

Highlighted Speakers

Ashley B. Boam
Ashley B. Boam
U.S. FDA
David M. Churchward
David M. Churchward
MHRA
Maura Kibbey
Maura Kibbey
United States Pharmacopeia
Oliver Meier
Oliver Meier
Novartis
Anthony Morandi
Anthony Morandi
AstraZeneca
Lorraine Nolan
Lorraine Nolan
Health Products Regulatory Authority (HPRA)
Anil Sawant
Anil Sawant
Merck & Co., Inc. / MSD
Cathie Vielle
Cathie Vielle
EDQM

Who Should Attend

  • Quality Assurance
  • Quality Affairs/External Affairs
  • Regulatory Affairs
  • Consultants Regulatory agency employees from international agencies Manufacturing
  • Quality Control

Registration Fees

Register Now
Registration Type Three Day Access One Day Access *
Member, Non-Member, Young Professional, Poster-Presenter € 949 € 449
Govern./Health Authority/Academic € 699 € 449

* To book a one-day access, please contact [email protected].


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