2023 PDA Quality and Regulations Conference

9:00

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

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.

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.

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.

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.

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.