9th GCC closed forum: CAPA in regulated bioanalysis; method robustness, biosimilars, preclinical method validation, endogenous biomarkers, whole blood stability, regulatory audit experiences and electronic laboratory notebooks | Zendy

Richard B. Hayes | Zendy; Richard LeLacheur | Zendy; Isabelle Dumont | Zendy; Philippe Couerbe | Zendy; Afshin Safavi | Zendy; Rafiq Islam | Zendy; Colin Pattison | Zendy; Stephanie Cape | Zendy; Mario L. Rocci | Zendy; Chad Briscoe | Zendy; Laura Cojocaru | Zendy; Elizabeth Groeber | Zendy; Luigi Silvestro | Zendy; Jennifer Bravo | Zendy; Ron Shoup | Zendy; Ma Verville | Zendy; Jennifer Zimmer | Zendy; Maria Cruz Caturla | Zendy; Ardeshir Khadang | Zendy; James S. Bourdage | Zendy; Nicola Hughes | Zendy; Saadya Fatmi | Zendy; Lorella Di Donato | Zendy; Curtis Sheldon | Zendy; Anahita Keyhani | Zendy; Christina Satterwhite | Zendy; Mathilde Yu | Zendy; Michele Fiscella | Zendy; James D. Hulse | Zendy; Zhongping Lin | Zendy; Wei Garofolo | Zendy; Natasha Savoie | Zendy; Yi Xiao | Zendy; Kai Kurylak | Zendy; Sarah Harris | Zendy; Manju Saxena | Zendy; Mike Buonarati | Zendy; Ann Lévesque | Zendy; Nadine Boudreau | Zendy; Jenny Lin | Zendy; Masood U Khan | Zendy; Gene Ray | Zendy; Yansheng Liu | Zendy; Allan Xu | Zendy; Gunjan Soni | Zendy; I. M. Ward | Zendy; Clare Kingsley | Zendy; Hanna Ritzén | Zendy; Edward Tabler | Zendy; Bob Nicholson | Zendy; Patrick Bennett | Zendy; Nico van de Merbel | Zendy; Shane Karnik | Zendy; Mohammed Bouhajib | Zendy; Jaap Wieling | Zendy; Daniel Mulvana | Zendy; Benno Ingelse | Zendy; Mike Allen | Zendy; Michele Malone | Zendy; Xinping Fang | Zendy

Open Access

9th GCC closed forum: CAPA in regulated bioanalysis; method robustness, biosimilars, preclinical method validation, endogenous biomarkers, whole blood stability, regulatory audit experiences and electronic laboratory notebooks

Author(s) -

Richard B. Hayes,

Richard LeLacheur,

Isabelle Dumont,

Philippe Couerbe,

Afshin Safavi,

Rafiq Islam,

Colin Pattison,

Stephanie Cape,

Mario L. Rocci,

Chad Briscoe,

Laura Cojocaru,

Elizabeth Groeber,

Luigi Silvestro,

Jennifer Bravo,

Ron Shoup,

Ma Verville,

Jennifer Zimmer,

Maria Cruz Caturla,

Ardeshir Khadang,

James S. Bourdage,

Nicola Hughes,

Saadya Fatmi,

Lorella Di Donato,

Curtis Sheldon,

Anahita Keyhani,

Christina Satterwhite,

Mathilde Yu,

Michele Fiscella,

James D. Hulse,

Zhongping Lin,

Wei Garofolo,

Natasha Savoie,

Yi Xiao,

Kai Kurylak,

Sarah Harris,

Manju Saxena,

Mike Buonarati,

Ann Lévesque,

Nadine Boudreau,

Jenny Lin,

Masood U Khan,

Gene Ray,

Yansheng Liu,

Allan Xu,

Gunjan Soni,

I. M. Ward,

Clare Kingsley,

Hanna Ritzén,

Edward Tabler,

Bob Nicholson,

Patrick Bennett,

Nico van de Merbel,

Shane Karnik,

Mohammed Bouhajib,

Jaap Wieling,

Daniel Mulvana,

Benno Ingelse,

Mike Allen,

Michele Malone,

Xinping Fang

Publication year - 2016

Publication title -

bioanalysis

Language(s) - English

Resource type - Journals

SCImago Journal Rank - 0.566

H-Index - 58

eISSN - 1757-6199

pISSN - 1757-6180

DOI - 10.4155/bio.16.16

Subject(s) - bioanalysis , biosimilar , audit , attendance , medicine , pharmacology , political science , business , chemistry , accounting , chromatography , law

The 9th GCCClosed Forum was held just prior to the 2015 Workshop on Recent Issues in Bioanalysis (WRIB) in Miami, FL, USA on 13 April 2015. In attendance were 58 senior-level participants, from eight countries, representing 38 CRO companies offering bioanalytical services. The objective of this meeting was for CRO bioanalytical representatives to meet and discuss scientific and regulatory issues specific to bioanalysis. The issues selected at this year's closed forum include CAPA, biosimilars, preclinical method validation, endogenous biomarkers, whole blood stability, and ELNs. A summary of the industry's best practices and the conclusions from the discussion of these topics is included in this meeting report.

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