Home » Events » Interactive Training in Applied GCP for Investigators, Researchers & Clinical Staff
Interactive Training in Applied GCP for Investigators, Researchers & Clinical Staff
28 February & 2, 7, 9 March 2022
The way clinical trials – industrial and academic – are conducted in the European Union has undergone a major change with the application of the Clinical Trials Regulation (Regulation (EU) No 536/2014) from 31 January 2022.
Strict adherence to Good Clinical Practice (GCP) principles ensures patient protection and reliable data. It is the basis for acceptance of publications and for patients’ access to new treatments. This standard has implications for all stakeholders and processes in clinical trials. However, despite overall commitment and best intentions to apply to these requirements, monitoring, audits and inspections regularly highlight findings of different levels of severity.
In this interactive 4 lunchtime lectures current experience and requirements of GCP-conform set-up and performance of clinical trials will be presented, their practical implications and examples discussed and pragmatic solutions for your daily practice elaborated.
A GCP certificate will be available upon participation of sessions 1, 3 & 4 (2 is optional) and passing the final test.
MD, PhD, FFPM, FBCPM Expert in Drug Development Planning and Site Management Support, Pharmaplex bv, Brussels, Belgium & Chairman of the Board of European Forum for Good Clinical Practice (EFGCP)
28 February Ethical Principles
1.00pm Welcome and Introduction 1.05pm Ethical Principles in the Declaration of Helsinki – Q&A 1.30pm ICH-E6(R2): Good Clinical Practice Principles and Guideline – Content, Questions & Answers 2.15pm The Informed Consent – Process, Q&A 2.35pm Ethical Aspects in Recruitment – Q&A 3.00pm End of Part 1
2 March (optional) The New Clinical Trial Regulation
1.00pm Welcome and Introduction 1.05pm Introduction to the new in the Clinical Trial Regulation 536/2014 (CTR)? Q&A 2.15pm CTR Aspects of Particular Relevance to Investigators and Academic Clinical Trials – Q&A 3.00pm End of Part 2
7 March Principal Investigators’ Responsibilities for a Clinical Trial at His/Her Site
1.00pm Welcome and Introduction 1.05pm Set-up of a Clinical Trial at the Site – Q&A 1.30pm Compliance in Document Management – Q&A 2.20pm Critical Elements in Conducting Clinical Trials – Q&A 2.35pm PI’s responsibilities in Safety Reporting in Clinical Trials – Q&A 3.00pm End of Part 3
9 March Risk-adapted Quality Management in Clinical Trials
1.00pm Welcome and Introduction 1.05pm Risk-adapted Management of Clinical Trials – Q&A 1.45pm Exercise: Critical Review of GCP Conditions Presented in a Publication 2.20pm Multiple Choice Test 3.00pm End of Part 4
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