Part 2: General Modifications
In the October 2013 revision, some definitions and statements that affect the informed consent process are explained in more detail which undoubtedly is a consequence of the current progresses attained in the clinical development activity.
These re-definitions in the General Principles of the Declaration are aimed to improve the Continue reading
Part 1: Background The Declaration of Helsinki (henceforth Declaration) is a set of ethical principles regarding experiments in humans that was developed for the medical community by the World Medical Association (WMA). It is widely regarded as the Continue reading
November 3, 2013. Another client has completed Learn@Regxia’s ICH GCP online training webinar, and we have received more great feedback! “This was the third time I have taken GCP training and the first time I learned why it is so important.” Continue reading
Health Canada has adopted the ICH Guidance Document :Periodic Benefit-Risk Evaluation Report. The Periodic Benefit-Risk Evaluation Report (PBRER) described in this guideline is intended to Continue reading
In September 2000, FDA issued the final rule “Administrative Practices and Procedures; Good Guidance Practices” (GGP). One aspect of the GGP regulation explains that the FDA will periodically review existing guidance documents to determine whether they need to be changed or withdrawn.
As such, the Center for Drug Evaluation and Research (CDER) has launched an initiative to review draft guidance documents published before 2010 in an effort to decide which guidances to withdraw, revise, or finalize Continue reading
The US Food and Drug Administration (FDA) has released a new guidance document bringing the agency into alignment with the International Conference on Harmonisation’s Continue reading
May 28, 2013. Another client has completed Learn@Regxia’s ICH GCP online training webinar, and we have received more great feedback! “Thank you for an informative training session.” Continue reading
The purpose of the GCP guidance document is to provide interpretive guidance to industry on the expectations of inspectors with respect to the adverse drug reaction and post-approval reporting requirements when conducting GVP inspections. Continue reading
Health Canada has issued a new name for its Post-Market Reporting Compliance (PMRC) inspection program. The program will now be called Good Pharmacovigilance Practices (GVP) in order to harmonize its terminology with its international regulatory partners. Continue reading