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2023 QR-1988x680

2023 PDA Quality and Regulations Conference

Nov 07 - Nov 08, 2023
Antwerp, Belgium

Building Supply Chain Resilience: A Holistic Perspective

  • Conference
  • Europe
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Program Highlights

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Overview

Dear Colleagues,

A very warm welcome on behalf of the Scientific Program Planning Committee and PDA. We are pleased to invite you to join us for the 2023 PDA Quality and Regulations Conference to take place as a face-to-face event on 07-08 November in Antwerp, Belgium. This global meeting is organized in close collaboration with an excellent Scientific Program Planning Committee which includes global industry leaders from Europe, Asia, and the U.S., supplier specialists, and a dedicated PDA support.

The overall program is designed to provide an update on regulatory and industry best practices with respect to shortages, there management and building Supply Chain Resilience. The pandemic has taught us that that regulatory flexibilities are available to offset shortages, but data demonstrates that miss forecasting / over sales and GxP issues remain the main causative factor of shortages. Listen to leading experts describe their approaches to dealing with these issues that facilitates dialogues between speakers and participants.

Following the success of the face-to-face meeting in Amsterdam in 2022, the 2023 PDA Quality and Regulations Conference will once again provide attendees the opportunity to socialize and learn from various members of the industry as well as regulators. This meeting continues to act as a discussion forum that allows for the direct interactions between industry and regulators and will continue to support sharing of best practices, lessons learned, applicability to your firms and a broader industry wide learning. Panel discussions and ample networking opportunities will complement an impressive scientific program and make it a worthwhile and well-rounded experience for you.

We look forward to seeing you in person in November!

Sincerely,
The Co-Chairs 

Vinny Browning III, Amgen
Patrick Costello, AbbVie

SCIENTIFIC PROGRAM PLANNING COMMITTEE

  • Vinny Browning III, Amgen
  • Patrick Costello, AbbVie
  • Karin Baer, NeuroDerm
  • Daniel Davis, GSK
  • Jette Johansen, Novo Nordisk
  • Stefan Muench, Körber
  • Valerie Mulholland, GMP Services
  • Hue Kwon, Samsung Bioepis
  • Stephan Roenninger, IFPMA
  • Eva Urban, CSL Behring
  • Carrie Horton, PDA
  • Falk Klar, PDA Europe
  • Sabine Hartmann, Manager Programs & Events, PDA Europe
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Agenda

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  • Day 1
  • Day 2

  • Tuesday, 7 November 2023

    9:00

    Welcome and Introduction
    Falk Klar, PDA Europe
    Vinny Browning III, Amgen
    Patrick Costello, AbbVie

    9:15 - 11:05 I Opening Session: Ensuring Product Supply an Industry and Regulatory Perspective
    Moderator: Patrick Costello, AbbVie

    Medicine Shortages – Insights on Causal Factors From a European Member State
    Darren Scully, HPRA

    Industry Perspective on Supply
    Stephan Rönninger, Amgen on behalf of IFPMA

    Decentralized Care and Patient Centric Supply Chain
    Pedro Mauri, Roche

    Q&A, Discussion

    11:05 - 11:35 I Coffee Break, Poster Session & Exhibition

    11:35 – 12:55 I Session 1: Application of Risk Management in Supply Chain Maturity
    Moderator: Stefan Münch, Körber
    The complexity of supply chains increases, thereby posing higher risk, evidently leading to rising shortages adversely affecting patients. Consequently, regulatory emphasis on product availability requires implementing Quality Risk Management (QRM) to address these challenges. Learn how modern QRM concepts help to manage and mitigate these risks and render supply chains more robust and resilient.

    Assuring Market Supply – The Nexus of Risk Management, Business Continuity and Key Metrics
    Scott Deckebach, Lachman Consultant Services, Inc. 

    Risk Management Application to Facilitate Outsourcing in the Regulatory Framework
    Andrew O'Connor, ERA Sciences

    Q&A, Discussion

    12:55 - 13:55 I Lunch Break, Poster Session & Exhibition

    13:55 - 15:25 I Session 2: Drug Shortage Prevention
    Moderator: Daniel Davis, GSK
    In this session we will discuss some of the real-life challenges and opportunities facing the industry in preventing potential Drug Shortages, together with some of the key factors in building supply chain resilience. We will begin with an overview of tools as result of the work being done by PDA as published in Technical Report 68 on practical risk-based approaches a marketing authorization holder (MAH) can take to prevent and address shortages, including insights on the development of Drug Shortage Prevention plans.  
    Following this we will discuss one of the key topics in Drug Shortage Prevention: the sourcing of single-use systems. These systems underpin much of the modern manufacturing supply chain for sterile and biologics, and their availability can be a particular challenge in ensuring the supply of Drug Products. A case study will be discussed where successful management was achieved through good collaboration with regulatory agencies, together with some of the risks related to potential regulatory divergence.

    Interactive Questionnaire

    Supply Chain Shortages - Root Causes and Practical Examples
    Emabelle Ramnarine, Boehringer-Ingelheim (remotly)
    Stephan Rönninger, Amgen (in person)

    Enabling the Reliable Supply of Single Use Components – Risk of Regulatory Divergence?
    Aidan Harrington, Arcadis DPS Group

    Q&A, Discussion

    15:25 - 15:55 I Coffee Break, Poster Session & Exhibition

    15:55 – 17:15 I Session 3: Practical Examples on Managing Resilience in Supply Chain
    Moderator: Karin Baer, NeuroDerm
    This session will discuss two different tools to systematically assess drug shortage risk factors to enable a resilience supply chain to ensure availability of medicinal products. The first approach will be based on academic research and discuss an approach on risk recognition and risk control with respect to supply chain, while the second presentation outlines a company’s journey as it identifies the key components of an effective plan to focus on strategies aimed at minimizing or prevent occurrence of shortages.

    Supply Chain Robustness and Resilience Applying Knowledge and Risk Management
    Valerie Mulholland, GMP Services

    Drug Shortages Prevention Plan Implementation: One Company’s Journey
    Johanna Diaz, Abbvie

    Q&A, Discussion

    17:15 I End of Conference Day 1 and Networking Event

  • Wednesday, 8 November 2023

    08:00 - 08:45 | PDA Quality System Interest Group Workshop - How Quality Management Maturity (QMM) Enhances Sustainability
    Moderators: Eva Urban, CSL Behring, Ghada Haddad, Merck & Michele Simone, Bracco
    The interactive IG Systems morning session will provide the opportunity to share best practices and challenges during the establishment and implementation of high QMM. 
    Sharing experiences in how high QMM is preventing supply chain disruptions and drug shortages

    09:00 | Welcome to Day Two from the Co-Chairs

    9:05 - 10:35 I Session 4: Hardening the Supply Chain for Increased Sustainability
    Moderator: Jette Johansen, Novo Nordisk
    Join us for an inspiring session that delves into the future of sustainable supply chains in the medical industry! Gain valuable insights from diverse perspectives as we explore current achievements and innovative possibilities to ensure a seamless and eco-friendly supply of medicinal products to our patients. Get ready to embark on a transformative journey towards a greener and more resilient supply chain.

    Regulatory Challenges to Decarbonisation of Single-use Medical Devices
    Marion Briggs, Alliance to Zero

    The Impact of Environmental, Chemical and Food Legislation on Medicines Supply: How to Address Through Innovation and Regulatory Flexibility
    Mónica Perea-Vélez, GSK

    Modifying Business Processes to Establish Sustainable Raw Material Supply
    Ryan Cleary, Amgen

    Q&A, Discussion

    10:35 - 11:05 I Coffee Break, Poster Session & Exhibition

    11:05 - 12:25 I Session 5: Pharmaceutical Quality Systems
    Moderator: Hue Kwon, Samsung Bioepis
    This session will discuss how the inspection landscape evolved over the last two decades and how the pandemic changed inspection practices. The use of data and metrics in Pharmaceutical Quality Systems (PQS) is becoming increasingly important for ensuring the reliability and efficiency of pharmaceutical supply chains. Hear about the future opportunities towards convergence relying on inspections conducted by a strengthened domestic inspectorate and a case study engaging PQS investment and advanced data driven approach to identify potential quality issues before they become significant problems.

    A 20-Year Inspection Practices Journey – Future Perspectives 
    Andrea Kurz, Roche on behalf of EFPIA

    Investing in Quality Systems to Drive Supply Chain Resilience 
    Mai Viholm, CSL Behring

    Q&A, Discussion

    12:25 - 13:25 I Lunch Break, Poster Session & Exhibition

    13:25 - 17:00 I Closing Session: Regulatory Positions and Strategies in Europe and Beyond
    Moderator: Vinny Browning III, Amgen
    In this session we will hear insights from our regulators on casual factors that have resulted in medicine shortages. We will also hear how a recall can also impact supply. As well as how changes in guidance documents and regulatory requirements can also impact supply. At the end of this session, we are very much looking forward to an open forum to continue our discussion around Supply Chain Resiliency with our Regulators and Industry experts.

    Interactive Questionnaire

    How Does the Israeli Moh Cope with EU GMP Annex 1 and Other Regulatory Requirements
    Rachel Shimonovitz, Israel Ministry of Health

    Recall Case Concerning the Presence of Multi-Drug Resistant Microorganisms in Antibiotic Capsules on the Danish Market
    Jeanne Majland & Thomas Pedersen, DKMA

    14:35 - 15:05 I Coffee Break, Poster Session & Exhibition

    Title to be Announced 
    Derek Smith, U.S. FDA

    Final Q&A and Panel Discussion
    Join our Discussion with Experts from the Industry and Regulatory:
    -     Ryan Cleary, Amgen
    -     Andrea Kurz, Roche on behalf of EFPIA 
    - Thomas Pedersen, DKMA
    - Darren Scully, HPRA
    -     Rachel Shimonovitz, Israel Ministry of Health  
    - Derek Smith, U.S. FDA

    Conference Summary from the Co-Chairs
    Vinny Browning III Amgen & Patrick Costello, AbbVie

    Closing Remarks & Farewell
    Falk Klar, PDA Europe

    16:35 I End of Conference

    Agenda is subject to change without notice, Speakers are invited, pending confirmation

Highlighted Speakers

Andrea Kurz
Andrea Kurz
Roche
Jeanne Majland
Jeanne Majland
DKMA
Darren Scully
Darren Scully
HPRA
Rachel Shimonovitz
Rachel Shimonovitz
Israeli Ministry of Health
Derek Smith
Derek Smith
U.S. FDA
Thomas Vestergaard Pedersen
Thomas Vestergaard Pedersen
DKMA
Mai Viholm
Mai Viholm
CSL Behring
View All

Additional Information

  • Who Should Attend
    Pharma Companies
    • Biopharmaceutical Companies
    • Start-ups/Emerging Companies
    Suppliers/Vendors
    • Raw Materials
    • Consumables
    • Equipment
    Governmental Health Authorities
    • National/Local Authorities
    • European Authorities
    • International Authorities
    Service Providers
    • CDMOs
    • Contract Test Laboratories
    • Logistic Companies
    Consultancy
    • Freelancer
    • Consulting Firms
    Academia
    • Universities
    • Academic Research Institutes

Got a Question? We have answers

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Travel

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

Hilton Antwerp Old Town

Groenplaats 32
Antwerp, Belgium

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  • Accommodations

    PDA recommends the reservation at the following hotel

    Hilton Antwerp Old Town
    Groenplaats 32
    B2000 Antwerp
    Belgium

    PDA Europe has reserved a limited number of rooms by 02 September 2023.

    Book your room at the PDA Group Rate via the above-mentioned reservation button.

  • Amenities

    We are in the heart of Antwerp, overlooking the Cathedral of Our Lady and the Old Town square. Shops, restaurants, and the Plantin-Moretus Museum are a short walk from our door. Antwerp Zoo and Antwerp Central Rail Station are within four kilometers. Enjoy all-day dining and drinks, 24-hour room service, fitness center access, and the rooftop sun deck.

How to Get Here

By Air

There are two airports close by, Antwerp International Airport wich is around 20 min by car or Brussle International Airport (Airport Zaventem) which is an hour away.

By Car

On site parting is available, please contact the hotel for further information.

Other Options

You can get their by train within 30 minutes from Antwerp international Airport.

Directions

Registration Fees

Early Registration
Registration Type Price by 10 September
Member €1.845
Non-member €2.145
Govern./Health Authority/Academic €870
Early Career Professional (Member) €870





Regular Registration
Registration Type Price after 10 September
Member €2.045
Non-member €2.345
Govern./Health Authority/Academic €970
Early Career Professional (Member) €970







Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

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