Pharma Lessons

ICH E6(R3) Guideline for Good Clinical Practice (GCP) (Principles & Annex 1) has been moved to Step 5. This means that the guideline is pending acceptance by health authorities and should come into effect on 23 July 2025.

database.ich.org

Good Clinical Practice guidelines are evolving. Read about some of the key aspects of the ICH E6 (R3) that are expected in 2025:

https://pharmaphorum.com/rd/unravelling-impact-ich-e6r3-good-clinical-practice

We are also preparing for the R3 Update but you can check the current version of our GCP training course at:

https://www.pharmalessons.com/certificate-courses/gcp-training-english/

Unravelling the impact of ICH E6(R3) on Good Clinical Practice The updated ICH E6(R3) Good Clinical Practice guidelines are here - discover what's changed and how clinical trials will need to adapt. This in-depth post unravels the key impacts of E6(R3).

Our Free Good Manufacturing Practice Training is a great way to get familiar with the GMP guidelines. Check it out here:

https://www.pharmalessons.com/free-courses/gmptraining/

GMP Training Free This is a completely free Good Manufacturing Practice course. It is a pleasant and beautifully designed online package. Try our GMP training and educate yourself!

Our free Good Distribution Practice training is based on the EU guidelines and is suitable for everyone who needs to get familiar with the basic principles of GDP.

https://www.pharmalessons.com/free-courses/gdptraining/

GDP Training Free This is a completely free Good Distribution Practice course. It is a pleasant and beautifully designed online package. Try our GDP training and educate yourself!

Good Pharmacovigilance Practice training online. Check out the short demo. Available is also a sample of the certificate:

https://www.pharmalessons.com/certificate-courses/gvp-training-english/

Pharmacovigilance Training - Online Course This is a certificate Good Pharmacovigilance Practice course. It is a pleasant and beautifully designed online package. Try our GVP training and educate yourself!

Quality by Design (QbD) principles should be adopted by sponsors to smooth the transition to E6(R3). Customer identification is fundamental to quality by design. Read more in the article:

https://www.clinicalleader.com/doc/who-are-your-tmf-customers-the-key-to-greater-trial-efficiency-quality-0001

While on the subject you may take a look at our free Good Clinical Practice Training:

https://www.pharmalessons.com/free-courses/gcptraining/

Who Are Your TMF Customers? The Key To Greater Trial Efficiency & Quality Could your director of clinical operations or TMF manager identify all customers of the TMF? Perhaps not. Learn why knowing all customers is so important to efficient, high-quality trials.

Good Manufacturing Practice training online with voice-over. Check out the short demo. Available is also a sample of the certificate:

https://www.pharmalessons.com/certificate-courses/gmp-training-english/

GMP Training - Online Course This is a certificate Good Manufacturing Practice course. It is a pleasant and beautifully designed online package. Try our GMP training and educate yourself!

The registration and listing deadline for companies affected by the Modernization of Cosmetics Regulation Act of 2022 has been extended by the FDA to July 1, 2024. Read more in the following article:

https://www.mintz.com/insights-center/viewpoints/2146/2023-11-13-fda-delays-enforcement-mocra-facility-registration-and

You can also take a look at our free Good Manufacturing Practice Training course:

https://www.pharmalessons.com/free-courses/gmptraining/

FDA Delays Enforcement of MoCRA Facility Registration and Cosmetic Product Listing Requirements Since the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) was signed into law, cosmetics companies have spent the past year preparing to comply with its provisions. This includes the facility registration and cosmetic product listing requirements that have were mandated by Congress in the....

Accredited GCP training online with voice-over. Check out the short demo. Available is also a sample of the certificate:

https://www.pharmalessons.com/certificate-courses/gcp-training-english/

GCP Training - Online Course This is a certificate Good Clinical Practice course. It is a beautifully designed online package accredited for 6.5 CPD credits. Try our GCP training and educate yourself!

Good Laboratory Practice training online. Check out the short demo. Available is also a sample of the certificate:

https://www.pharmalessons.com/certificate-courses/glp-training-english/

GLP Training - Online Course This is a certificate Good Laboratory Practice course. It is a pleasant and beautifully designed online package. Try our GLP training and educate yourself!

An interesting article about the future of pharmacovigilance and how technology can improve PV practices and medicines safety:

https://pharmaphorum.com/digital/how-technology-redefining-pharmacovigilance

Do not forget to get familiar with our free Pharmacovigilance training course:

https://www.pharmalessons.com/free-courses/gvptraining/

GVP (Good Pharmacovigilance Practice) Training Free This is a completely free Good Pharmacovigilance Practice course. It is a pleasant and beautifully designed online package. Try our GVP training and educate yourself!