Thank You for Making the 2016 ISPE Europe Annual Conference a Great Success

 

With more than 330 participants, the 2016 Europe Annual Conference had a strong theme that resonated through-out the entire conference – Innovation, Integration and Integrity.  Highlights included:

  • Strong scientific-technical programming
  • Accomplished speakers and influential regulator presentations
  • Thought-provoking discussions
  • Engaging networking opportunities
  • Enthusiasm from attendees

2016 ISPE Europe Annual Conference 2016 ISPE Europe Annual Meeting

Executive Forum
The Forum brought together industry leaders and regulators who strategized on benchmarking, metrics, and regulatory initiatives.

2016 ISPE Europe Annual Conference - Executive Forum2016 ISPE Europe Annual Conference - Executive Forum

Keynote Sessions
ISPE was proud to welcome four distinguished keynote speakers, who delivered engaging and inspiring presentations.  Speakers included:

  • Paige Kane, Director Knowledge Management/Researcher at DIT and Pfizer
  • Dr. Theodora Kourti, Sr. Vice President, Global Regulatory Affairs at ISPE
  • Mark Birse, Group Manager Inspectorate at MHRA
  • Dr. Bruno Mouton, Vice President, Auditing and Compliance at Merck Serono

2016 ISPE Europe Annual Conference - Keynote Speaker2016 ISPE Europe Annual Conference - Keynote Speaker

Education Tracks:

2016 ISPE Europe Annual Conference - Education Track2016 ISPE Europe Annual Conference - Education Track

  • Regulatory:
    Attendees received first-hand information about current regulatory challenges from:
    • Dr. Celia N. Cruz, Acting Branch Chief/CMC Review, FDA
    • Patrick Costello, Scientific Administrator Manufacturing and Quality Compliance and Inspections, EMA
    • Mark Birse, Group Manager Inspectorate at MHRA
    • Andrew Hopkins, Expert Inspector, MHRA
    • Dr. Susanne Keitel, Director, EDQM Council of Europe

    Notable regulatory topics included Annex 1 and Water for Injections.

  • Facilities of the Future:
    Companies like Johnson & Johnson, Hoffmann - La Roche, and GlaxoSmithKline showcased how they are implementing continuous manufacturing of pharmaceutical products for commercial manufacturing. In addition, attendees heard about the USA FDA's position on continuous manufacturing, emerging technologies, and the next generation of aseptic processing.
  • Data Integrity:
    Presenters focused on the practical solutions and industry best practices on how to implement an effective Data Integrity Management programme.  A highlight included the regulatory guidance received from MHRA and WHO on how to manage a Corporate Data Integrity Programme.

  • Investigational Products:
    Attendees received privileged insight into innovative technologies on JIT packaging and eLabels by Janssen. Case studies about Cell & Gene Therapy and Clinical Trial Supply illustrated alternative supply options, risks, and optimisation potential. Additionally, the track offered six interactive workshops that spurred discussion and exchange with leading industry experts about Import/Export Compliance aspects and Personalised Medicines.

2016 ISPE Europe Annual Conference - Education Track2016 ISPE Europe Annual Conference - Education Track

Presentation Handouts

Download the Presentation Handouts »

Presentations will be available for 30 days after the conference ends.

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