Early Confirmed 2015 Speakers

Norwegian Medicines Agency
Dr Øyvind Holte
Scientific Officer, EMA PAT Team
Norwegian Medicines Agency
Eli Lilly
Paul Desmond
QCL Consultant
Eli Lilly
Hovione
Nuno Matos
PAT Specialist
Hovione
FMC Health and Nutrition
Brian Carlin
Director of Open Innovation
FMC Health and Nutrition
Novartis
Jacques Wiss
Senior PAT Expert
Novartis
Bristol-Myers Squibb
Sushil Srivastava
Process Research and Development Director
Bristol-Myers Squibb
Lonza Group
Tobias Merz
PAT Team Lead
Lonza Group
H. Lundbeck A/S
Morten Alleso
QbD and PAT Specialist
H. Lundbeck A/S
Novo Nordisk
Michael Schousboe
Principal Specialist Quality Risk Management
Novo Nordisk
Novo Nordisk
Sune Klint Anderson
Principal Scientist
Novo Nordisk
Sanofi Pasteur
Baptiste Berruee
Statistical Analyst, Data Warehouse Project Leader
Sanofi Pasteur
Vertex Pharmaceuticals
Justin Pritchard
Senior Scientist
Vertex Pharmaceuticals
UCB Pharma
Edith Norrant
Innovations Technology Sciences Director
UCB Pharma
Medical Products Agency
Mats Welin
Senior Expert, EMA PAT Team
Medical Products Agency
GlaxoSmithKline
Melanie Dumarey
Chemometrician
GlaxoSmithKline
Novartis
Vishal Rosha
Senior Scientist BioProcess Research and Development
Novartis

Maximise Production Efficiency, Reduce Production Cycle Time, Reduce Cost and Increase Product Quality with PAT and Quality by Design

The annual PAT and QbD Conference is heading into its 12th year with an outstanding line up of speakers and content. Bringing you exclusive regulatory insight, brand new case studies of PAT and QbD implementation, strategies to achieve process control and movement towards continuous manufacturing.

This event is focused on interaction, with a goal to facilitate discussion and problem solving through a variety of panel discussions and round table sessions!

The integration of PAT and QbD into production cycles has been hindered largely due to the high cost of restructuring production lines, a lack of evidence on ROI and a fear of regulatory scrutiny. The 2015 PAT and Quality by Design Conference addresses these issues head on by bringing regulatory experts and industry leaders together for an open and compelling discussion.

Providing you with the essential info!

Regulatory insight: what are the expectations of regulators? What are the critical requirements in applications? How have the approaches of regulators changed over the evolution of PAT and QbD processes? Regulatory experts share their experiences with PAT and QbD and their perspective on the best approach to achieving a successful application.

PAT and QbD case studies: industry leaders share their experiences with integrating PAT and QbD into their production cycles. Looking at the challenges faced, the strategies implemented and the impact it’s had.

Continuous Manufacturing: evaluating the benefits of moving from batch to continuous processing. Gain insight into tool selection, placement and monitoring and how to deal with atypical results.

Data: how to use real-time data to make real-time decisions.

Key topics of 2015:

  • Interpreting and applying the regulatory guidelines
  • Understanding the requirements and expectations of regulators with submissions
  • Case studies of PAT and QbD implementation and its impact
  • Moving from batch to continuous processing
  • Determining your risk management strategies
  • How to make data-driven decisions


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