May still be relevant for non-marketing authorization trials (consult the guideline for details). Until then, ICH E6 (R2) remains the live, valid and applicable GCP guideline for quality-focused ...

Good Clinical Practice (GCP), the bedrock of ... Requirements for Pharmaceuticals for Human Use (ICH) released the ICH E6(R3) draft guideline for public consultation in May 2023 in collaboration ...

No matter how many times you have done it, it’s an incredible feeling to publish an article. Seeing months, maybe years of hard work finalised, ready to go out into the world and earn recognition, is ...

Our studies are conducted under GCP as described in the US Code of Federal Regulations (CFR), Title 21, CFR, Parts 50 and 312 and International Council on Harmonisation (ICH) Guidelines for GCP.

The ICH M12 Guideline was finalized on May 21st, 2024, after extensive review of industry and other comments. The Guideline was the culmination of the extensive work by the Expert Working Group.

why there is a need for the guideline the areas the guideline will and will not cover what it intends to achieve. A draft scope is provided to organisations with an interest in the topic (known as ...

The SWITCH trial is another recently published study that is going to affect the upcoming ICH guidelines, according to Steiner. In SWITCH, which was stopped early due to a lack of funding ...

New Diagnostic Criteria for Alzheimer's Will Change Practice With new blood biomarker tests, Alzheimer's disease will no longer be just a diagnosis of exclusion. Medscape Family Medicine ...

These guardrails include an evaluation by an impartial ethics board that weighs the risks and benefits and full informed consent by the participants, governed by policy rubrics, applicable statutes, ...

For the first time in a decade, the American Stroke Association, a division of the American Heart Association, has updated its Guideline for the Primary Prevention of Stroke with a series of new ...

The transaction is structured to include long-term performance incentives designed to align GCP International leadership with the interests of fund clients and Ares stockholders. The acquisition ...