Unified CROs Influence on
Global Harmonization of Bioanalytical Guideline
CLOSED FORUM
The need to Build a Global CRO Council
Many colleagues from CROs have pointed out the importance of having a "strong and unified CROs influence" on the Global Harmonization of the Bioanalytical Regulations, and of having CROs and pharmaceutical companies "equally represented" to lead this harmonization process.
With no doubt, Global Harmonization of Bioanalytical Regulation is going to strongly, profoundly and positively impact how CROs function for the following reasons:
The majority of bioanalytical CROs work under the strictest regulatory standards, and because they operate globally they have to deal with different regional issues and regulations.
Differences in guidance documents (e.g.: EU-EMA, Brazil-ANVISA, Japan-MHLW, China-SFDA, Australia-TGA) are becoming a serious hurdle for CROs that have to submit studies for different health agencies.
Newly established bioanalytical CROs to support bioequivalence studies for generic drugs in emerging economies (e.g.: Asian Pacific, Latin America and Eastern Europe) are struggling between trying to comply with both national and international guidelines.
CVG has committed to promptly react to the above requests by organizing a special closed forum only for colleagues working in bioanalytical CROs for "discussing, reviewing, sharing perspectives, providing potential solutions and agreeing upon an unified approach on how to Influence the Global Harmonization of Bioanalytical Regulations as CROs".
A Global CRO Council (GCC) will be instituted at this Closed Forum with involved CROs as Member Companies, and all the participants will be part of the authorship of an influential document based on the conclusion of the closed forum.
Moving forward, the Global CRO Council will address not only the global harmonization topic, but also any other issues in the regulated bioanalyis field in order to provide inputs from CRO community and contribute to the global pharmaceutical industry.
A platform for member companies to discuss day to day common issues in bioanalysis;
A foundation to voice CRO opinions and generate scientific documents (white papers);
A channel to communicate with global regulatory agencies.
