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Update in Clinical research & GCP – Copenhagen 23rd October 2017
Refreshments & Registration from 8.30am
• EU Clinical Trial Regulation 2014 No. 536
A brief overview of the finalised Regulation awaiting implementation
• Risk proportionate approaches in clinical trials
Summary of the latest EMA Recommendations
• Pharmacovigilance update
Inspectors want to see that all staff have some basic PV knowledge. This session will
provide an update on what’s new as well as to provide some PV basics.
• Inspection expectations for the Trial Master File
Highlights of the EMA’s Trial Master File draft Reflection Paper
• Q&A using keypads on the draft EMA Serious breaches guideline
• EMA First-in-Human Guidance
A summary of EMA’s 2017 guideline on first-in-human studies
• Latest news on what’s coming and new
Including: AxMPs, modernization of ICH E8 and its knock on impact on ICH GCP E6,
Delegated Regulation on GMP affecting
Ideal update and refresher consisting of executive summaries of the latest developments and discussion of clinical research topics to satisfy ongoing training needs.
The programme changes for each seminar to cover new topics, guidelines and regulations of relevance to a clinical research professional.
The seminars are suitable for those who need to update their general knowledge and to demonstrate recent and up-to-date training:
those overseeing or actively managing clinical trials as sponsors, monitors, auditors, investigators, supervisors and administrators; academics;
those responsible for research governance, members of ethics committees and site personnel involved in both commercial and non-commercial trials covered by European legislation.
These seminars also provide suitable continuing education for those who have attended the Academy's Cert CRGCP Parts 1 and 2 programme.
A certificate of attendance will be issued at the end of the day to all participants who attend the seminar.
Events are normally held in the UK and Denmark.