The Executive Forum will offer pharmaceutical executives, senior experts and future decision makers a platform to interactively examine the current challenges in technical operations and dominant factors to achieving successful pharmaceutical manufacturing, namely — safety, efficiency and compliance during development, transfer, production and distribution.
In particular, the executive session will focus on ensuring supply chain integrity, managing lean and compliant operations and avoiding drug shortages.
Dr. Martin Bergen, Managing Director of SecurPharm will focus on the implementation of the Falsified Medicines Directive, Delegated Acts and Mass Serialisation. How companies can prepare systems and processes for drug delivery effectively and in time.
Dr. Paul Rutten, Principal at McKinsey & Co, the Netherlands will talk about the perceived trade-off between fulfilling GMP compliance and lean production based on benchmark studies undertaken by McKinsey and Co. An interactive session will provide opportunity for dialogue and sharing experiences.
Drug Shortages - a Multi-layered Challenge Across the Whole Supply Chain.
Input and updates from industry experts and agencies will reflect on the current drug shortages initiatives. Discussions will incorporate FDA guidance, the EMA reflection paper, the ISPE industry survey and the latest updates on the industry-regulator dialogue on preventative concepts and best practice examples to avoid drug shortages. Dialogue will also focus on the robustness of the installed pharmaceutical quality systems, the relevance of quality culture and behaviours within corporations. Join the discussion and contribute to the action plan being developed in Europe to mitigate shortages.
Highlights of the Executive Forum:
Who should attend?
The Executive Forum is meant for Executives, Senior Experts and Future Decision Makers from all Functions in Pharmaceutical Operations, Development, Regulatory Affairs, Quality, Production, Engineering Management and Supply Chain Management.
|13.00 – 13.15||
Opening and Welcome
Official Welcome Address by Dr. Karl-Heinz Menges, Pharmacist, Regierungspraesidium Darmstadt / Regional
|13.15 – 14.00||
SecurPharm – The German Solution against Falsified Medicines
Dr. Martin Bergen, Managing Director, SecurPharm Germany
|14.00 – 14.30||Networking Break|
|14.30 – 16.10||
The Big Challenge for Pharmaceutical Operations in Europe: Managing Compliance and Quality under
New Requirements and the Perceived Trade-Off to Lean, Agile and Flexible Production
Dr. Paul Rutten, Principal at McKinsey & Co, the Netherlands
|16.10 – 16.15||
Drug Shortages: Update and Request for Input on Initiatives Aimed at Preventing Shortages
Introduction to speakers, topics and objectives: Dr. John Berridge, Strategic Advisor, ISPE
|16.15 – 16.35||
EMA initiatives on Drug Shortages
Dr. Brendan Cuddy, Scientific Administrator, European Medicines Agency (EMA)
|16.35 – 17.00||
The Inter-Association Shortages Prevention Project
Dr. John Berridge, Strategic Advisor, ISPE, and Emma Ramnarine, Senior Director, Head Global Biologics QC Network, Genentech Roche/PDA Task Force Leader for TR54 QRM and TR54 Annex 4 Drug Shortages, PDA
|17.00 – 17.25||
The Inter-Association Shortages Communication Project
Dr. Birgitte Holst, Director, Novo Nordisk/ Member of Technical Development and Operations Committee, EFPIA, and Julie Marechal-Jamil, Senior Manager Quality & Regulatory Affairs at European Generic Medicines Association (EGA)
|17.25 – 17.50||
Moderator: Dr. John Berridge, Strategic Advisor, ISPE
Panellists: Speaker line-up from the Drug Shortages Topic, including Dr. Jacques Morenas, Deputy Director, Inspectorate and Companies Department, ANSM, and Mark Birse, Group Manager GMDP, MHRA
|17.50 - 18.10||
Dr. Thomas Zimmer, Vice President, European Operations, ISPE
Executive Forum Chair:
Vice President, European Operations, ISPE
Dr. Martin Bergen,
Managing Director, securPharm, Germany
Strategic Advisor, ISPE, UK
Scientific Administrator, EMA, UK
Director, Novo Nordisk/ Member of Technical Development and Operations Committee, EFPIA, Denmark
Senior Manager Quality & Regulatory Affairs at European Generic Medicines Association (EGA), Belgium
Dr. Karl-Heinz Menges,
Pharmacist, Regierungspraesidium Darmstadt / Regional Council Darmstadt, Germany
Senior Director, Head Global Biologics QC Network, Genentech Roche/PDA Task Force Leader for TR54 QRM and TR54 Annex 4 Drug Shortages, PDA, US
Principal, McKinsey & Co, the Netherlands