Real-World Data: Digitalizing A Patient’s Prescription Journey In Japan
The industry is turning towards real-world data to create more [...]
How Real-World Data is Revolutionizing Rare Oncology Drug Development
Rare diseases have smaller patient populations, which make drug development [...]
Clinical Studies In Japan Today: Another Look At The World’s Second-Largest Prescription Drug Market In A Post-Pandemic World
The Latest Insights into Clinical Studies in Japan The Pharma [...]
[Whitepaper] Gateways To Asia: Market Access In Japan And South Korea
Expanding to Asia can be a logical next step for [...]
The Emergence of Digital Therapeutics: Building A Future
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Managing Manufacturing in Times of Uncertainty
Virtual pharmaceutical companies often have strong regulatory and clinical teams, [...]
[White Paper] Evolving Trends of Decentralized Clinical Trials in Japan
As of December 2020, after the first wave of the [...]
[Whitepaper] New Pharma Opportunities And Market Access Challenges In Japan
New Pharma Opportunities And Market Access Challenges In Japan Download [...]
[Whitepaper] Drug Manufacturing And Development In The Age Of Precision Medicine
Development and Manufacturing: Insights into the Precision Medicine Model Download [...]
[White Paper] Tailoring Bioanalytical Testing In A New Era Of Drug Development
For decades, analytical testing has played a critical role at [...]
[White Paper] How the fast-changing R&D pipeline is amplifying the importance of adaptable CROs
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[White Paper] Recommendations on the interpretation of the new European Medicines Agency Guideline on Bioanalytical Method Validation by Global CRO Council for Bioanalysis (GCC) Gallery[White Paper] Recommendations on the interpretation of the new European Medicines Agency Guideline on Bioanalytical Method Validation by Global CRO Council for Bioanalysis (GCC)
[White Paper] Recommendations on the interpretation of the new European Medicines Agency Guideline on Bioanalytical Method Validation by Global CRO Council for Bioanalysis (GCC)
Senior representatives of GCC member companies have thoroughly evaluated and discussed the new European Medicines Agency (EMA; July 2011 [1]) Guideline on Bioanalytical Method Validation (BMV), during the 4th GCC (23 October 2011, Washington DC, USA) and 5th GCC (14 November 2011, Barcelona, Spain) Closed Forums. These North American and European events provided a unique opportunity for CRO leaders to openly share opinions and perspectives and to agree on unified bioanalytical recommendations specifically in relation with the new EMA guideline.
[White Paper] Recommendations on: internal standard criteria, stability, incurred sample reanalysis and recent 483s by the Global CRO Council for Bioanalysis Gallery[White Paper] Recommendations on: internal standard criteria, stability, incurred sample reanalysis and recent 483s by the Global CRO Council for Bioanalysis
[White Paper] Recommendations on: internal standard criteria, stability, incurred sample reanalysis and recent 483s by the Global CRO Council for Bioanalysis
The 2nd Global CRO Council (GCC) for Bioanalysis Closed Forum was held on 15 April, 2011 in Montreal, Canada. In attendance were 45 senior-level representatives from 39 CROs on behalf of eight countries.
[White Paper] Recommendations on Incurred Sample Stability (ISS) by the Global CRO Council (GCC)
The topic of Incurred Sample Stability (ISS) has generated considerable discussion within the bioanalytical community in recent years. The subject was an integral part of the 7th Annual Workshop on Recent Issues of Bioanalysis (WRIB) held in Long Beach, California, USA, in April 2013, and at the Global CRO Council (GCC) meeting preceding it.
[White Paper] GCC Recommendations on Bioanalytical Method Stability Implications of Co-administered and Co-formulated Drugs
An Open Letter written by the GCC describing the GCC survey results on stability data from co-administered and co-formulated drugs was sent to multiple regulatory authorities on 14 December 2011. This letter and further discussions at different GCC meetings lead to subsequent recommendations on this topic of widespread interest within the bioanalytical community over the past two years.
