EBF Focus Workshop - Taking tiered approach to the next level

Call for Speakers and Registration 

17-18 June 2014,NH Sablon hotel, Brussels, Belgium.

INTRODUCTION

Tiered approach, fit-for-purpose, qualified or validated methods,….it has become part of the bioanalysts vocabulary over the last years. However, as an industry, we didn’t come together yet to ensure harmonized thinking on how to apply this in our day to day work. Following up on the sustained discussions in EBF, considering the discussions in the GBC and capitalizing on the discussions at the recent Crystal City –V meeting in Baltimore, EBF is now ready to organize a dedicated non-sponsored workshop to discuss and define tangible processes for methods other than validated methods and take tiered approach to the next level.

This Focus Workshop is organized in NH Sablon, Brussels (in the historic center of Brussels, with good connection to Zaventem airport, Brussels South international train station). The meeting starts 17 June 2014 at 9.00h and ends 18 June2014 at 16.00h

Aim of the meeting

The aim of the meeting is twofold. On the one hand, we will try to get industry agreement on which studies require validation as per Guidance or which can be supported using the principles scientific qualification (i.e. screening or qualified assays). Second, we will try to work out more practical details on method performance tests to be included and acceptance criteria to be applied for assays for different study types or stages of development. The outcome will be published and allow the industry to use a robust and consolidated scientific approach when applying method qualification.

The meeting will be held in a true workshop format, with limited number of presentations and a lot of time for interactive breakouts as well as plenary workshop discussions to ensure we have captured everybody’s input.

Who should attend?

The meeting is open for industry, academia and health authority professionals with vested interest on how to balance regulated bioanalytical validation requirements with increased scientific freedom in a tiered approach scheme for method qualification. Essential to make this meeting a success is a strong representation from Pharma/CRO scientist with experience in small and large molecule bioanalysis and quality assurance, able to influence internal bioanalytical validation strategies.

CALL FOR SPEAKERS

For this workshop we look for your contribution as a presenter. As mentioned above, to allow time for discussion and round table workshop activities, the number of presentations is limited to five (20 minutes each). Also your presentation should focus on the key aspects of the problem statement and provide a good overview of the issues for our industry or solutions applicable for all. Please send your title and abstract to focus@europeanbioanalysisforum.eu prior to 15 May 2014

REGISTRATION IS OPEN

Participation to the meeting is 320 Euro (After 10 June, we only accept on-site registration at an increased fee of € 400 (cash only, no credit cards)). The fee includes entrance to the workshop, food and beverages during lunch, coffee breaks and a cocktail reception on the first evening. Dinner and lodging is not included. In order to allow a multi-company multi-angle discussion, a maximum of 5 delegates per company is suggested and the meeting is capped at 120 delegates.

Register for the meeting: fill out attached registration form and send to admin@europeanbioanalysisforum.eu

Book your hotel: fill out attached hotel reservation form and send to c.devos@nh-hotels.com (prior to 17 May 2014 at special conference rate)

MEETING ORGANISATION

John Smeraglia, UCB - Stuart McDougall, Covance - Philip Timmerman, Janssen R&D - Magnus Knutsson, Ferring - Steve White, GlaxoSmithKline - Morten Anders Kall, Lundbeck - Margarete Brudny Kloeppel, Bayer Pharma AG