With news, trainings and conferences, a comprehensive guidelines database, publications and more the ECA is the leading European training and information services provider in the GMP and GDP environment.
There are many new developments and change notifications in the GMP area keeping the pharmaceutical industry busy, not least because many of the new requirements must be implemented soon. Read moe in our GMP Update Part 2.
The ICH recently published a reflection paper on “GCP Renovation” regarding the modernization of ICH E8 (General Considerations for Clinical Trials) and the subsequent renovation of ICH E6 (Guideline for Good Clinical Practice). Read more about ICH´s Reflection Paper on the potential renovation of the ICH guidelines related to clinical trials.
Critical violations in view of the inspected studies as well as serious deficiencies in the quality management system of two Indian study sites were found during GCP inspections. Read more on the findings of the GCP inspections conducted at two Indian Sites.
The U.S. Food and Drug Administration (FDA) recently published a Questions and Answers (Q&A) guidance on the use of electronic informed consent in clinical investigation. Read more about the FDA Guidance "Use of Electronic Informed Consent Questions and Answers".
The EudraGMDP Database contains GMP and GDP Compliance and Non-Compliance reports. From January 2016 until today six GDP non-compliance reports have been published. Please read more about the GDP Non-Compliance reports.
Having in mind a proper needs assessment many companies in the field are considering the outsourcing of their logistic activities. But when it comes to the decision making definite decisions are required. Support provides a 12-steps guide for the outsourcing of logistics activities.