One Day Course: GCP and Clinical Research Update – Hot Inspection Topics (London, United Kingdom – August 9, 2019) – ResearchAndMarkets.com

and Clinical Research Update – Hot Inspection Topics”

conference has been added to ResearchAndMarkets.com’s

This course provides an update on recent changes to ICH GCP R2, EU
Clinical Trial Regulation and guidance and will discuss how these
changes have been implemented

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

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.

This is a highly interactive course suitable for those who need to
refresh their knowledge and to demonstrate recent and up-to-date
training to regulatory inspectors.

Benefits of attending:

  • Discuss recent developments in GCP and clinical trial legislation and
  • Identify common audit and inspection findings and discuss how to
    prevent these occurring
  • Understand the impact on clinical trials of recent GCP principles and
    regulatory standards such as the EU Clinical Trial Regulation
    (536/2014) and GDPR (2016/679)
  • Clarify requirements for clinical QMS and QTLs (quality tolerance

Who Should Attend:

The course is of particular relevance for those working in clinical
research, regulatory affairs and pharmacovigilance It will also be of
interest to those departments who liaise/ support clinical trial
personnel and all other professionals who want to know more about
updates in GCP regulations and guidelines covering clinical trials.


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
  • 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
  • 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


Dr. Laura Brown

Pharmaceutical Management and Training Consultant

University of Cardiff

Dr Laura Brown MBA, BSc (Biochemistry), BSc (Psychology), PhD, Diploma
in Clinical Science, FICR, is a Pharmaceutical Management and Training
Consultant, Course Director for the MSc in Clinical Research at the
University of Cardiff, and MSc Regulatory Affairs, TOPRA.

For more information about this conference visit https://www.researchandmarkets.com/r/8fa4i7


Laura Wood, Senior Press Manager
[email protected]
E.S.T. Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call
For GMT Office Hours Call +353-1-416-8900
Topics: Drug

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