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Press release content from Business Wire. The AP news staff was not involved in its creation.

1-Day Course: GCP and Clinical Research Update - Hot Inspection Topics (London, United Kingdom - September 24, 2019) - ResearchAndMarkets.com

March 12, 2019

DUBLIN--(BUSINESS WIRE)--Mar 12, 2019--The “GCP and Clinical Research Update - Hot Inspection Topics” conference has been added to ResearchAndMarkets.com’s offering.

Clinical research is a constantly evolving field and the regulatory requirements are regularly being updated. In order to stay up to date and maintain your GCP knowledge, it is important to receive regular training.

This course provides an update on recent changes to relevant legislation and guidance and will discuss how these changes have been implemented. Topics covered will include ICH GCP R2, the EU Clinical Trial Regulation, data integrity and the impact of GDPR on clinical trials. The programme will discuss inspection findings and common failings in these new areas and how these should be addressed.


Brief review of regulatory authority inspections findings

  • Hot inspection topics, including EMA, MHRA and FDA findings

New EU Clinical Trial Regulation (536/2014) - overview and update including new supporting documents

  • Review of the key changes including the new clinical trial application process
  • Update on the additional guidance and directives
  • Compliance considerations for serious breaches

ICH GCP E6 R2 - practical examples of implementation to comply with inspectors’ expectations

  • Update on the revision of ICH GCP R2
  • Practical implications of the key changes
  • Requirements for clinical QMS and QTLs (quality tolerance limits)
  • Hot topics discussion, including procedures for certified copies’

Oversight - how to demonstrate and document for CRO oversight and investigator oversight

  • How to demonstrate oversight of the investigator and expanded responsibilities under ICH GCP R2
  • How to meet inspectors’ expectations for sponsor oversight of CROs and other vendors

Risk management - new requirements for GCP compliance

  • Quality risk management requirements
  • Risk-based monitoring
  • Examples of risk-based tools to demonstrate compliance

Data integrity

  • The latest requirements and new regulatory guidance from MHRA, FDA, EU
  • Computer System Validation
  • Avoiding data integrity breaches
  • The TMF Guideline on GCP compliance in relation to trial master file (paper and/or electronic) for content, management, archiving, audit and inspection of clinical trials (2017)

GDPR (General Data Protection Regulation) requirements for clinical trials

  • Penalties for non-compliance and reporting serious data breaches
  • Overview of key requirements including informed consent, contracts with suppliers, responsibilities of data controllers and data processors
  • Preparation of data protection impact assessments for clinical trials

Q & A and other hot topics

  • Brief overview of other recent GCP developments including electronic informed consent

Summary, action plans and final Q & A

For more information about this conference visit https://www.researchandmarkets.com/research/sd8b2c/1day_course_gcp?w=4

View source version on businesswire.com:https://www.businesswire.com/news/home/20190312005465/en/

CONTACT: ResearchAndMarkets.com

Laura Wood, Senior Press Manager


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Related Topics:Drug Discovery



SOURCE: Research and Markets

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PUB: 03/12/2019 07:46 AM/DISC: 03/12/2019 07:46 AM


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