2014 Europe Annual Conference

2014 Europe Annual Conference

2014 Europe Annual Conference

 

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Education Details

View the Conference Programme ( 429 KB)

View the Conference Flyer ( 899 KB)

Conference Programme Committee

Chair

 PhotoJean-Francois Duliere
Pharmaceutical Process Technologist, Technip Life Sciences, France

 

 

 

 

 

Co-Chair

 PhotoDr. Gabriele Wanninger,
Head of the Department Pharmacy, Inspectorate Southern Bavaria, Government of Upper Bavaria, Germany

 

 

 

 

 

Track 1: QbD - Reality Today? Implementation and Beyond

Track Leaders: 
 PhotoGeorges France
Region Head Quality Europe, Novartis Consumer Health Services SA, Switzerland

 Photo Dr. Susanne Keitel,
Director, EDQM, France

 PhotoJean-Louis Robert,
Head of Department, National Health Laboratory, LNS, Luxembourg

 

 PhotoJohn Berridge
Strategic Advisor, ISPE, UK

 

 

 

Track 2: Quality Risk Management (QRM)

Track Leaders: 
 PhotoBryan Wright
European Regulatory Affairs Advisor, ISPE, UK

 PhotoMark Birse, 
Group Manager GMP/GDP Inspection, MHRA, UK

 

 

 

Track 3: Pharmaceutical Facilities of the Future

Track Leader: 
 PhotoGert Moelgaard
Vice President, Strategic Development, NNE Pharmaplan, Denmark

 

 

 

Keynote Sessions

Keynote speakers from industry and regulatory authorities will define the New Quality Culture and share their perspectives on:

  • The future of biopharmaceutical operations in a stronger competitive market – Prof. Dr. Wolfram Carius, Sanofi Frankfurt, will discuss future challenges in Biopharmaceuticals.
  • Current challenges - John Pinion, Head of Global Quality from Roche, will highlight how the Quality System of a global player addresses current and future regulatory challenges, while ensuring control over manufacturing cost.
  • Quality management in a cross-industry comparison - Joe de Feo, Juran Institute will highlight the most effective principles of managing quality and compliance and how they can be employed in the pharmaceutical industry.
  • Regulations have changed over the last few years and will continue to change in the future. Hear the latest regulatory perspectives on the implementation of the new regulations, how regulators continue to work with the industry and the current changes to the regulatory framework.

Conference Tracks 

Track 1: QbD - Reality Today? Implementation and Beyond

Track Leaders: Georges France, Region Head Quality Europe, Novartis Consumer Health Services SA, Switzerland
Susanne Keitel, Director, EDQM, France
Jean-Louis Robert, Head of Department, National Health Laboratory, LNS, Luxembourg  

Gain a deeper understanding of:

  • The major challenges of QbD implementation in pharma and biotech operations through interactive workshops
  • Regulatory approaches for QbD, including both Regulator and Industry views on meeting regulatory expectations in Europe and the USA
  • How the principles of QbD could be applied to your current portfolio? What are the criteria of choice? Life Cycle Management of CMC and change management
  • Views from the EMA/Industry workshop on QbD

Track 2: Quality Risk Management (QRM)

Track Leader: Bryan Wright, European Regulatory Affairs Advisor ISPE, UK
Mark Birse,  Group Manager GMP/GDP Inspection, MHRA, UK

Learn about:

  • Practical methods required for the implementation of new requirements
  • How to improve your company’s GMP compliance?
  • The new challenges that the industry is facing to prepare risk assessments for multi-product use of facilities that will be acceptable to the regulatory authorities
  • QRM best practices

Join us for a unique opportunity to hear about and contribute to the development of the European action plan to prevent shortages resulting from manufacturing problems.

Track 3: Pharmaceutical Facilities of the Future

Track Leader: Gert Moelgaard, Vice President, Strategic Development, NNE Pharmaplan, Denmark

Gain knowledge on:

  • New manufacturing technology for commercial manufacturing
  • Practical solutions and experiences with “Facilities of the Future”
  • Flexible solutions for smaller batches, shorter lead-times and personalization of drugs
  • EMA and FDA observations and recommendations for future facilities

Who Should Attend?

The Conference is aimed at Pharma Development Experts, Quality Management, Quality Assurance, Quality Operations, Quality Control, Quality Systems, Production & Distribution Personnel, Professionals Involved in Manufacturing, Development and Technology Transfer as well as Suppliers and Regulators with Interest in New Solutions and Experiences.

Thank you to our Top Tier Sponsors

  • Pinnacle Sponsor
  • Pinnacle Sponsor
  • Pinnacle Sponsor
  • Silver Sponsor
  • Bronze Sponsor
  • Media Partners

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