2023 PDA Quality and Regulations Conference

Antwerp, Belgium
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Program Highlights

Looking forward to meeting you in Antwerp! Don't forget to register!

Note: PDA is committed to deliver safe and secure in-person events. In conjunction with the venue and vendors supporting our event, PDA strictly adheres to all national, provincial and local government regulations. PDA is closely monitoring the situation and will continue to update this information if required. 

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, their 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!

The Co-Chairs 

Vinny Browning III, Amgen
Patrick Costello, AbbVie


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

Standard Registration

Member Price


GovernmentMember Only


Health AuthorityMember Only


Early Career ProfessionalMember Only


AcademicMember Only




See Qualifying Criteria for Member Types.


WAYS TO REGISTER: 1. Online Registration   2. [email protected]

PDA MEMBERS: Please remember to log in before registering If you come from a Governmental or Health Authority Institution or from an Academic Organization, please contact [email protected] before registering.

If you need to apply for a visa to enter the event country, PDA Europe must be informed of this fact at least 4 weeks before the start of the event.

Day 1

Tuesday, 7 November 2023


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
This engaging opening plenary explores product supply with insights from regulators and industry experts. Delve into regulatory perspectives on medicine shortages in an EU Member state, learn more about industry strategies for supply chain resiliency, and the impact of decentralized care and patient-centric supply chains on overall supply chain enhancement.

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 & 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 a 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
Patrick Day, 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 & 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 a result of the work being done by PDA as published in Technical Report No. 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 this session: 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 & Exhibition

15:55 – 17:15 I Session 3: Practical Examples on Managing Resilience in Supply Chain
Moderator: Stefan Münch, Körber
This session will discuss two different tools to systematically assess drug shortage risk factors to enable a resilient supply chain to ensure the availability of medicinal products. The first approach will be based on academic research and discuss an approach to risk recognition and risk control with respect to the 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 the 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

Day 2

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 Interest Group 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 Decarbonization 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 & 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 & Exhibition

13:25 - 17:00 I Closing Session: Regulatory Positions and Strategies in Europe and Beyond
Moderator: Vinny Browning III, Amgen
In this session, regulators will share their strategies and evaluations in Europe and beyond. Discover how EU GMP requirements, including Annex 1, are assessed, and applied. Explore a real-life case of an antibiotic capsule recall in the Danish market and the valuable lessons learned from it. Conclude with a regulatory perspective on ensuring product resiliency in the supply chain. Stay for an open forum to discuss supply chain resiliency with 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 & Exhibition

Regulatory Efforts in Ensuring High-Quality Pharmaceutical Products
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
Agenda is subject to change.

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.

PDA recommends the reservation at the following hotel

Hilton Antwerp Old Town
Groenplaats 32
B2000 Antwerp

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.

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.