We are proud to have brought together some of the most prominent pharmaceutical, regulatory and technology experts from around the world!
In-depth educational sessions, training courses and networking events provided attendees the opportunity to exchange ideas with industry experts and colleagues. Here's a recap of the first ISPE Europe Annual Conference.
Download the conference handouts here.
|Dr. Fergus Sweeney, Head of Inspections & Human Medicines Pharmacovigilance Division, EMA||Prof. Dr. Juergen Bongs, Head Pharmaceutical Sciences Quality Assurance Global Quality Operations, Sanofi|
|Dr. Sweeney gave an update on the regulatory changes that are impacting manufacturing and marketing authorisations at a European and National Competent Authority level||Mr. Bongs explained how the biotechnology industry is currently entering a new cycle of development|
|John Pinion, Global Head of PT Quality & Compliance, Roche||Carol Bye, Head Pharmaceutical Sciences Quality Assurance Global Quality Operations, Pfizer|
|Mr. Pinion described how and why the pharmaceutical and biotechnology organisations are required to successfully address the rapidly changing needs of multiple stakeholders||Mrs. Bye gave an external view outside of the pharmaceutical industry in order to encourage all organizations to adopt a new quality philosophy and framework.|
Dr. Paul Rupp introduced us to the securPharm project, a directive designed by the EU to fight the on-going threat of falsified medicines.
Dr. Paul Rutten, Principal and McKinsey & Co, the Netherlands
Dr. Rutten taught us how to manage compliance and quality under new requirements and explained the perceived trade-off to lean, agile and flexible production.
Dr. John Berridge, Strategic Advisor, ISPE
Dr. Berridge brought us up-to-date on the new association and regulatory initiatives that have been initiated since the publication of the ISPE Drug Shortages Survey report in June 2013
Dr. Brendan Cuddy, Scientific Administrator, EMA
Brendan Cuddy shared with us information about the legal structure on drug production, as well as on the major issues and causes for drug shortages in Europe. He also took a closer look at various EMA initiatives and actions, and their implementation.
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
This session brought together representatives from all the associations contributing to an Inter-Association Task Force that is responding to the EMA’s request to submit to them a report on how shortages can be prevented.
Dr. Birgitte Holst, Director, Novo Nordisk/ Member of Technical Development and Operations Committee, EFPIA, and Julie Marechal-Jamil, Senior Manager Quality & Regulatory Affairs at EGA
Dr. Holst and Mrs. Marechal-Jamil offered an overview of the current and desired state on quality related drug shortages, and lectured communication principles on potential shortages.
Track 1 highlighted the new quality paradigm that can be defined as a shift from a pure compliance approach to a more proactive one. Meanwhile, quality should be secured by integrating the risk management approach all along the scientific development.
A key objective in this track was to ensure the robustness of manufacturing processes and to facilitate technological innovation, and the final goal is to provide high tech and high quality pharmaceutical product to patients.
Track 2 contributed to the ISPE Drug Shortages Prevention Plan, the Society’s second major output on this topic since launching its Drug Shortages Initiative in 2012. This second phase of the Initiative is aimed at addressing the root causes of drug shortages to prevent delay of supply. The 2013 survey provided clear evidence that mitigating shortages requires a holistic approach that encompasses both the organizational and technical issues affecting drug manufacturing and quality.
The ISPE’s Drug Shortages Prevention Plan will feature an organization and product lifecycle approach to ensure a more reliable supply of medicines through development of company-wide drug shortages strategic plans, aligned governance, good communication, on-going capability building (which includes training), proactive regulatory interaction and integrated quality systems.
Track 3 focused on new manufacturing technology for commercial manufacturing and proposed some flexible solutions for smaller batchers, shorter lead-times and personalization of drugs. Finally, EMA and FDA made some observations and recommendations on how to handle these facilities.
The ISPE Europe Annual Conference also featured several networking opportunities during breaks or lunches to share knowledge, experiences and innovative ideas.