ICH E8 (R1) FINAL Guideline on General Considerations for Clinical Studies (January 20, 2022)

The International Council for Harmonisation (ICH) is committed to developing timely technical requirements for pharmaceuticals for human use in a manner that is responsive to the needs of the global community.

Clinical studies of medicinal products are conducted to provide information that can ultimately improve access to safe and effective products with meaningful impact on patients, while protecting those participating in the studies. ICH E8(R1) provides guidance on the clinical development lifecycle, including designing quality into clinical studies, considering the broad range of clinical study designs and data sources used.

In October 2021, ICH published the FINAL ICH E 8 Guideline on General Considerations for Clinical Studies R(1)ICH - this means it is to be implemented by the clinical research industry NOW!!! . Organizations are to evaluate, NOW, their practices and determine what they would need to do - to in compliance with the final ICH E8 (R1).

Join us for the course, with Liz Wool, FACRP, CCRA, CID and CMT. Liz is an international speaker and trainer for foundational and advanced clinical research topics to excellent reviews. Further, Liz's passion and expertise emanates through the webcam to Learners internationally. This will not be a boring session.

The learning objectives include the following:

1. Describe the General Principles in ICH E8 (R1)
2. Discuss designing QUALTY into clinical trials
3. Explain drug development planning
4. Identify clinical study design elements and data sources for clinical studies
5. Assess trial execution activities that includes study conduct, participant safety and study reporting
6. Interpret considerations in identifying critical to quality factors

 

International Conference for Harmonisation (ICH) E6 Good Clinical Practice (GCP) Pending Revision 3 in 2022 (January 21, 2022)

The International Council for Harmonisation (ICH) is committed to developing timely technical requirements for pharmaceuticals for human use in a manner that is responsive to the needs of the global community.

In early 2022, it Is expected that ICH will publish Revision 3 draft for the clinical research industry. The global research community follow ICH E6 GCP as described in protocols or local law and regulation. The research community ALWAYS give attention to the DRAFT changes published in order for organizations to evaluate their practices and determine what they would need to do - to in compliance with the final ICH E6 GCP Guideline, when published.

Join us for the course, with Liz Wool, FACRP, CCRA, CID and CMT. Liz is an international speaker and trainer for foundational and advanced clinical research topics to excellent reviews. Further, Liz's passion and expertise emanates through the webcam to Learners internationally. This will not be a boring session.

The learning objectives include the following:

1. Describe the reasons for a third revision (R3) to ICH E6 GCP
2. Discuss the overarching principles document added to ICH E6 GCP (R3)
3. Explain the new ANNEXEs that are added to ICH E6 E6 GCP (R3)

 

*Attend this course to learn, share, and engage with the virtual training platform and with Liz!

*Attend this course - ready to have your 'web camera on' - this makes the training - like a community - class of Learners with Liz!

 

Who Should Attend

President, Vice-President, Director, Managers and Scientist from CRO or Pharmaceutical Company from the following organizations/departments.
Sponsor/Pharma Organizations - Formulation Development, Regulatory Affairs, Analytical/Bio-analytical Development, Quality Control, Quality Assurance, Investigator Site Management, Outsourcing Management, Auditors
CRO/Clinical Trials Organizations - Clinical Research and Development, Analytical Method Development, IT & Data management, Pharmacovigilance, Medical Affairs R&D and Strategic issues, Business Development.

For details of the event, please contact Ms Pooja Sharma at p.sharma@glostem.com or call 7696325050, 7696525050 or WhatsApp: 9041725050.
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Conference Agenda

  • Designing QUALTY into Clinical Trials
  • Reasons for a Third Revision (R3) to ICH E6 GCP
  • Considerations in Identifying Critical to Quality Factors
  • Overarching Principles of Document added to ICH E6 GCP (R3)

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