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2020 Quality Regulations

Quality and Regulations Conference

Jun 09 - Jun 10, 2020
Dublin, Ireland

  • Conference
  • Europe

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Program Highlights

Dear Colleague,

The manufacture of drugs and drug products is one of the most closely regulated activity in the industry. The core of Good Manufacturing Practice is defined and determined by a variety of guidelines and regulations issued and updated regularly by national and international authorities. These have direct implications for the development, manufacturing, and reliable distribution of pharmaceutical parenteral products.

This and more will be the focus of the 2020 PDA Europe Quality and Regulations conference, presented as a virtual conference. 

By joining this two-day event, attendees will ensure to receive the most current and thorough information on recent and most important changes in the regulatory landscape.

In the era of breakthrough medicinal therapies and accelerated R&D, Lifecycle and Change Management, Knowledge and Risk Management as well as availability of these drugs become pivotal milestones. Dive into the new decade with PDA by exploring Digital Solutions in Quality and don’t miss out on learnings on impurity controls and control strategy!

Sincerely,

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

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
  • Tuesday, 9 June 2020

    9:00
    Welcome and Introduction

    Falk Klar, PDA Europe

    9:05
    PDA Updates and Awards Ceremony

    Richard Johnson, President, PDA
    Jette Christensen, Chair, PDA Board of Directors

    9:10
    Conference Overview by the Conference Chairs

    Barbara Allen, Eli Lilly
    Frank Hallinan, Consultant

    Opening Plenary: Quality and Regulations
    Moderator: Barbara Allen,
    Eli Lilly

    9:20
    HPRA & EMA Strategy 2020 – 2025 / Consequences of Brexit
    HPRA

    9:45
    Manufacturing in a New Decade and What it Means for Regulations & Quality
    MSD

    10:10
    Quality Culture – The Pathway to the Future
    Janssen, J&J

    10:35
    Q&A, Discussion

    11:00 - 11:30
    Coffee Break, Poster Session & Exhibition

    Session 1A: Q10-Enabler: Quality Risk Management
    Moderator: Frank Hallinan,
    Consultant

    11:30
    A Regulator's Perspective on Quality Risk Management & Knowledge Management after 12 Years

    HPRA

    12:00
    An Industry Perspective on How Quality Risk Management Does and Will Enable an Effective Pharmaceutical Quality System

    MSD

    12:30
    Q&A, Discussion

    Session 1B: Digital Solutions in Quality
    Moderator: Toni Manzano,
    Bigfinite

    11:30
    CPV of the Future: Better Understanding of the Upstream Process
    Universitat Autonoma Barcelona

    12:00
    Digital Change Implementation in the Context of CMC Transformation
    Sanofi

    12:30
    Q&A, Discussion

    13:00 - 14:00
    Lunch Break, Poster Session & Exhibition

    Session 2A: Q10-Enabler:Knowledge Management
    Moderator: Lothar Hartmann,
    Phact

    14:00
    A Framework for Realization of Knowledge Management as a PQS Enabler
    Technological University Dublin

    14:30
    How Knowledge Management Enables a PQS and How Management Review Supports It
    Bracco

    15:00
    Q&A, Discussion

    Session 2B: Global Pharmacopoeias In The Broader Regulatory Context
    Moderator: Mervin Browning,
    Amgen

    14:00
    Updates on Monographs and Chapters & Recent Developments in Biologics
    United States Pharmacopeia

    14:30
    European Ph. Updates for the New Decade
    EDQM, invited

    15:00
    Q&A, Discussion

    15:30 - 16:00
    Coffee Break, Poster Session & Exhibition

    Session 3A: Data Integrity – Evolution
    Moderator: Barbara Allen,
    Eli Lilly

    16:00
    What is Data Integrity in a Quality Management System
    GSK

    16:30
    Data Integrity – Mission Unaccomplished
    Parexel

    17:00
    Q&A, Discussion

    Session 3B: Lifecycle Management: Tech Transfer & Validation
    Moderator: Karen Casey,
    Janssen J&J

    16:00
    PDA Technical Report Revision #65 on Tech Transfer
    Speaker invited

    16:30
    Validation & Automation
    Janssen Biologics

    17:00
    Q&A, Discussion

    17:30
    End of Conference Day 1 & Networking Event


  • Wednesday, 10 June 2020

    Session 4A: Inspection Programs
    Moderator: Anne Hayes,
    HPRA

    9:00
    Inspection Models and Experience
    HPRA

    9:30
    Evolution of Compliance and Cost of Quality
    US FDA, invited

    10:00
    Q&A, Discussion

    Session 4B: Lifecycle Management – Change Management
    Moderator: Graham Cook,
    Pfizer

    9:00
    Demonstrating Effectiveness of a Pharmaceutical Quality System for Post Approval Change
    Roche Pharma

    9:30
    ICH Q12 Implementation from a Chemistry, Manufacturing and Controls Perspective
    GSK

    10:00
    Q&A, Discussion

    10:30 - 11:00
    Coffee Break, Poster Session & Exhibition

    Session 5A: Drug Shortages
    Moderator: Patrick Costello,
    AbbVie

    11:00
    Regulatory Update: EU and US Programs
    European Medicines Agency (EMA)

    11:30
    An Industry Approach to Drug Shortage Prevention
    Amgen

    12:00
    Q&A, Discussion

    Session 5B: Quality In Practice
    Moderator: Karin Baer,
    Janssen J&J

    11:00
    QMS for Continuous Manufacturing: A Case Study
    Eli Lilly

    11:30
    Leveraging Modern Technologies: Improving Overall Product Quality and Meeting Regulatory Compliance - Case Study
    Speaker, invited

    12:00
    Q&A, Discussion

    12:30 - 13:30
    Lunch Break, Poster Session & Exhibition

    Closing Plenary: Control Strategy/ Global Quality Assurance In The New Decade
    Moderator: Frank Hallinan,
    Consultant

    13:30
    The Global Supply Chain and US Regulatory Trends
    US FDA

    14:00
    The Evolving Regulatory Environment: Where We Are and Where We Move To
    HPRA / PIC/S

    14:30 - 15:00
    Coffee Break, Poster Session & Exhibition

    15:00
    Control Strategies: A Foundation for Quality and Regulatory Flexibility
    MHRA

    15:30
    N-nitrosamine Impurities: Actions, Lessons Learned and Next Steps
    Novartis

    16:00
    Closing Panel Discussion, Q&A:
    The Evolution of Quality - A New Decade

    16:20
    Conference Summaries by the Conference Chairs
    Barbara Allen,
    Eli Lilly & Frank Hallinan, Consultant

    16:30
    End of Conference & Farewell


Highlighted Speakers

Ashley B. Boam
Ashley B. Boam
U.S. FDA
David M. Churchward
David M. Churchward
MHRA, UK
Brendan Cuddy
Brendan Cuddy
European Medicines Agency (EMA)
Anne Hayes
Anne Hayes
HPRA, PIC/S
Maura Kibbey
Maura Kibbey
United States Pharmacopeia
Martin Lipa
Martin Lipa
MSD / TU Dublin
Lorraine Nolan
Lorraine Nolan
Health Products Regulatory Authority (HPRA)
Siegfried Schmitt
Siegfried Schmitt
PAREXEL

Additional Information

  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    Who Should Attend

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

Got a Question? We have answers

Contact Us

Travel

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Dublin, Ireland

How to Get Here

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Directions

Registration Fees

Early Registration
Registration Type Price by 19 April
Member €1.595
Non-member €1.895
Poster-Presenter Member €1.645
Poster-Presenter Non-member €1.945
Govern./Health Authority/Academic €700
Young Professional (Member) €700
All fees given in Euro, excluding VAT (23%)





































Regular Registration
Registration Type Price after 19 April
Member €1.795
Non-member €2.095
Poster-Presenter Member €1.845
Poster-Presenter Non-member €2.145
Govern./Health Authority/Academic €900
Young Professional (Member) €900
All fees given in Euro, excluding VAT (23%)





































* For this member type or discounted rate, online registration is not available and must be faxed in.

† You must be a member to receive this rate.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Group Registration Discount

Register 3 people from the same organization as a group (at the same time) for the Conference or Workshop and receive the 4th registration free. Other discounts cannot be applied.

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If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

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SUBSTITUTION: If a substitution request is sent 30 days before the event, no fee will be charged. After this period, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent 30 days before the event, a full refund will be given minus a $200 fee. After this period, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to [email protected]. Phone messages are not accepted.

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