2014’s Expert Speakers include:

 Inna Ben-anat
Inna Ben-anat
Director, head of Qbd and product robustness
Teva
 Pedro Hernandez
Pedro Hernandez
Director of Quality by design
Merck Serono
 Mingzhong Li
Mingzhong Li
principal lecturer in the pharmaceutical technologies
De Montfort University
 Julian Morris
Julian Morris
Director
Centre for Process Analytics and Control Technology (CPACT)
 Alain Poncin
Alain Poncin
continous improvement manager
Octoplus (part of Dr Reddy's laboratories)
 Sushill Srivastava
Sushill Srivastava
Process Research and Development Director
Bristol-Myers Squibb
 Jesus Zurdo
Jesus Zurdo
Head of innovation, biopharma development
Lonza
 John Purves
John Purves
Former
EMEA
 Lawrence Yu
Lawrence Yu
Acting Director, Office of Pharmaceutical Science
FDA
 Peter Hamilton
Peter Hamilton
Senior PAt Scientist
GlaxoSmithKline
 David Gervais
David Gervais
Senior process Scientist
Public Health England
 flavien Susanne
flavien Susanne
Chemical engineer
Novartis
 Peter Boogaard
Peter Boogaard
CEO
Industrial Lab Automation

Maximise cost efficiency, improve quality and cut waste through Quality by design

80% of companies plan to invest in Quality by Design and PAT solutions, yet 72% do not have a fully established process in place. But what is the reason for this gap? 59% of people stated it was due to internal lack ofexpertise.

This is where we come in. For the past 11 years, Pharma IQ’s annual conference has been bringing you the latest case studies to help show you how to effectively implement Qbd into your company. This year is no different with 16 key regulators and leading representatives from across pharma, generic and the biologic industry who can share with you practical strategies for putting a successful process in place. Plus brand new this year hear about how other industries implement Qbd and what the role of continuous manufacturing has in aiding the process.

What’s more the event will outline the regulatory requirements associated with quality by design, allowing for a smoother and more efficient approval process. It is these discussions and interactions with regulators which will help shape the future of successful approvals within your company.

That’s why we’ve built this year’s agenda to not only focuson the implementation of Qbd, but the regulatory requirements of implementation.

Key topics include:

  • What the regulators expect from filings and how this can be achieved, with key updates on current regulatory requirements along with results from the latest FDA/EMA parallel pilot study
  • How to implement the most effective QBD process in order to maximise profit and case studies from leaders in the industry on how this has been done
  • The future of Qbd in Biologics: overcoming the problems of heterogeneity and data variation
  • The implementation of QBD in the generic industry: how the industry are coping with the mandatory requirement
  • Latest advances in PAT technology and the best implementation practice of these techniques
  • Moving from batch manufacturing to continuous manufacturing, how to effective implement this, how this will aid quality by design and overcoming the problem of defining a batch

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