Don’t miss the opportunity to engage with top European regulators including:
- Henrike Potthast, Pharmaceutical Assessor, BfArM
- Jose Morais, Pharmaceutical Assessor, INFARMED
- Kersti Oselin, Medical Assessor, MHRA
- Christoph Baumgaertel, Assessor, AGES
- Tamas Paal, President Scientific Board, National Institute of Pharmacy, Hungary
Along with a wealth of industry case studies, including:
- Sandra van Os, Head Clinical Operations, Synthon BV
- Carlos Camozzi, Medical Director, Orphan Europe
- Keith Powell, CEO, Polytherics
- Helmut Schütz, CEO, BEBAC
- Ole Østerberg, Clinical Research Scientist, Neurosearch
- Richard Peck, Director Regulatory Affairs, Finox
- Ahmad Mohammed, Senior Formulation Associate R&D, Reckitt Benckiser
- Rene Holm, Head of Pre-formulation, Lundbeck
Implementing New Guidelines to Optimise Bioequivalence and Bioavailability studies: Reducing Costs and Speeding Approvals
Pharma IQ is pleased to announce the dates for the Bioequivalence and Bioavailability Studies Conference taking place on 26th-27th October 2010. Bioequivalence and bioavailability are an essential part of regulatory approval process for generic and innovator companies and with the arrival of new EMA guidelines (on 1st August 2010) and the expanding scope of the generics market, it is now a crucial time to explore the impact of these guidelines and the changes they are bringing.
The guidelines permit increased flexibility regarding study design, as well as providing recommendations on BCS-based biowaivers and new approaches to study requirements for different dosage forms. The conference is bringing together several of the drafting committee to address these changes to help optimise your bioequivalence studies.
The Bioavailability and Bioequivalence conference offers the opportunity to discover new approaches to design, conduct and evaluation of bioequivalence studies to achieve more rapid approval for NCEs or generic products. Join us in Munich to discuss successfully implementing biowaivers, optimising bioavailability, developing biosimilars and much more!
What the event will discuss:
- The EMA guidelines, impact since implementation and clarification of changes
- Choosing the optimum bioequivalence study design to save time and money
- Assessing PKPD data through use of modelling and simulation techniques
- Establishing IVIVC
- Investigating the application of biowaivers and their cost saving potential
- Exploring the possibility of bioequivalence studies for biosimilars and the approval process in Europe and USA
- Optimising bioavailability and improving the dissolution of poorly soluble compounds
Download the Brochure for complete details of the agenda.
Past Pharma IQ delegates comments:
Great mix of presenters covering a comprehensive range of topics – well done. Superb networking opportunityPfizer
Interesting & willing to create discussion and to elaborate the presented themes. It was valuable.Hovione Farmaciencia SA
Who you will meet:
Heads and managers of:
|
|
Benefits of attending
- Explore the new EMA guidelines changes to enhance the design, execution and evaluation of bioequivalence studies
- Evaluate new parameters in study design: implement a biostatistical approach to save time and reduce costs and understand the practicalities of bioequivalence when conducting paediatric studies
- Harness the time-saving potential of biowaivers for generic products to surpass the need for bioavailability studies
- Determine IVIVC, reduce in vivo studies and implement effective modelling and simulation techniques to establish bioequivalence
- Hear first hand regulatory expectations and gain first time approval when establishing bioequivalence for different dosage forms
- Minimise costs through reducing the number of studies for modified and extended release products
- Optimise bioavailability and improve the dissolution rate of poorly soluble compounds
