chevron_left Categories

Other related webinars

Essential Regulatory Perspectives and Best Clini...

Monday, 7th February, 2011
Time : 01:00 PM EST | 10:00 AM PST

Biggest challenge for Pharmaceuticals/ Biotechno...

Tuesday, 22nd February, 2011
Time : 10:00 AM | 07:00 AM

Critical aspects of applying QbD to pharmaceutic...

Friday, 6th May, 2011
Time : 02:00 PM | 11:00 AM

Biologics Battlefield: Opportunities and Obstacl...

Thursday, 30th June, 2011
Time : 02:00 PM | 11:00 AM

Vital Success/Failure Regulatory Perspectives an...

Thursday, 15th September, 2011
Time : 02:00 PM | 11:00 AM

Good Laboratory Practices (GLP) Compliance and A...

Friday, 11th November, 2011
Time : 02:00 PM | 11:00 AM

Good Clinical Practice (GCP): FDA Regulations, S...

Thursday, 26th January, 2012
Time : 02:00 PM EST | 11:00 AM PST

Orphan Drugs in Europe – How to use observatio...

Friday, 1st June, 2012
Time : 02:00 PM EST | 11:00 AM PST

Implementing the Compliant Good Laboratory Pract...

Friday, 10th August, 2012
Time : 02:00 PM EST | 11:00 AM PST

An overview of an innovative patient-centric ser...

Wednesday, 12th September, 2012
Time : 02:00 PM EST | 11:00 AM PST

An overview of Translational Medicine

Friday, 21st September, 2012
Time : 02:00 PM EST | 11:00 AM PST

Optimizing Site Selection for Global Clinical Tr...

Friday, 26th October, 2012
Time : 02:00 PM EST | 11:00 AM PST

Optimal clinical supply planning for global drug...

Friday, 16th November, 2012
Time : 02:00 PM EST | 11:00 AM PST

Patient Recruitment & Retention Management in Cl...

Monday, 10th December, 2012
Time : 02:00 PM EST | 11:00 AM PST

GMP's for Dietary Supplements: Keys to Success w...

Thursday, 30th October, 2014
Time : 01:00 PM EST | 10:00 AM PST

Is It Safe? A Cautionary Tale and Practical Guid...

Friday, 9th January, 2015
Time : 02:00 PM EST | 11:00 AM PST

How To Reconcile ICH GCP With RISK BASED Monitor...

Thursday, 19th March, 2015
Time : 11:00 AM IST | 06:30 PM BET

Orphan Drugs : Regulation and Reimbursement Cond...

Friday, 22nd July, 2016
Time : 01:00 PM EST | 10:00 AM PST

Panel Discussion on Best Practices to Clinical T...

Friday, 10th March, 2017
Time : 04:00 PM IST | 11:30 AM BST

FDA Requirements for Good Clinical Practice’s ...

Friday, 7th July, 2017
Time : 04:00 PM IST | 11:30 AM BST

Implementation of Pharmaceutical Quality system ...

Friday, 17th November, 2017
Time : 01:00 PM EST | 10:30 AM PST

FDA Guidance for ICH GCP E6 R2 Means for Sponsor...

Thursday, 27th September, 2018
Time : 04:00 PM IST | 03:30 AM PDT

Managing Human Error in Quality Systems: Human E...

Friday, 17th July, 2020
Time : 01:00 PM EST | 10:00AM PST

FDA approvals of Orphan Drugs and Rare Diseases:...

Friday, 24th July, 2020
Time : 01:00 PM EST | 10:30 AM PST

FDA approvals of Orphan Drugs and Rare Diseases:...

Friday, 26th August, 2022
Time : 01:00 PM EST | 10:00 AM PST

Good Documentation Guideline (Chapter <1029> USP...

Friday, 11th November, 2022
Time : 01:00 PM EDT | 10:00 AM PST

FDA - Investigating OOS results

Friday, 17th March, 2023
Time : 01:00 PM EDT | 10:00 AM PDT

Best Practices for FDA's Investigating Deviation...

Friday, 26th May, 2023
Time : 01:00 PM EDT | 10:00 AM PDT

Recorded Webinar

FDA Guidance for ICH GCP E6 R2 Means for Sponsors and CROs

timelapse 60 mins with 10-15 mins of Q and A

Note:

This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times

Speaker/Presenter

Short Abstract

FDA Guidance for Good Clinical Practice (GCP) is an international quality standard defined by the International Council for Harmonization (ICH) that governs ethical and scientific considerations for designing, conducting, recording and reporting trials involving human subjects. Compliance with FDA Guidance for GCP in clinical trials helps to assure that the rights, well-being and safety of trial participants are protected and that the data generated in the trial is credible.

Learning Highlights:

  • Introduction " The Principles of ICH GCP"
  • Identify three changes that impact sponsors/CROs and individual roles
  • Explain the impact of the revisions on clinical trial conduct and organizational practices
  • Discuss opportunities for implementing the revised guideline


Apply for this webinar

Content Disclaimer

Contents in our website are from external websites. Links to and content from external website are provided for the convenience of users. Biopractice.com takes no responsibility for the content of such links and websites.

//