Clinical Evaluation of Medical Devices: The Clinical Evaluation Report Training Course
1-2 Dec 2021 - Online webinar
Also on: 1 Feb 2022
Cover all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance documents
Clinical Quality Management Systems Training Course
Clinical Trial Regulatory Requirements Training Course
27-28 Jan 2022 - Online webinar
Also on: 14 Jul 2022
This course will take you through the key regulatory and guideline requirements for clinical research in Europe, including the new EU Clinical Trial Regulation and existing Directive requirements.
Data Integrity and Document Management Training Course
4 Oct 2021 - Online webinar
Also on: 5 Apr 2022
Data integrity is a critical issue in document governance and is increasingly becoming a focus for regulatory inspections globally. This course will equip you with the necessary knowledge to identify and avoid potential data integrity issues before auditors do.
EU (European Union) Clinical Trial Regulation: Overview and Implementation Training Course
18-19 Oct 2021 - Online webinar
Also on: 10 Jan 2022
This course will provide an essential understanding to help with compliance with the new regulation and associated implementing acts and other texts for carrying out clinical trials in the EU
GCP (Good Clinical Practice) and Clinical Research Update - Hot Inspection Topics Training Course
24 Sep 2021 - Online webinar
Also on: 10 Mar 2022
This course provides recent updates on the EU Clinical Trial Regulation, other EU, MHRA and FDA requirements, consideration for managing Covid-19 for studies in the future and technology developments
Managing Vendor/CRO (Contract Research Organisation)/CMO (Contract Manufacturing Organisation) Oversight Training Course
Medical Device Studies: Clinical Evidence Training Course
Medical Device Studies: Regulatory Requirements and Adverse Event Reporting Training Course
22-23 Sep 2021 - Online webinar
Also on: 9 Mar 2022
An essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow-up requirements and adverse event and vigilance reporting.
Practical Implementation of GCP (Good Clinical Practice) in Veterinary Field Studies Training Course
26-27 Oct 2021 - Online webinar
Also on: 28 Apr 2022
This seminar will take many aspects of animal health and veterinary research and development through a typical clinical trial, and pay attention to compliance with Good Clinical Practice (GCP) as outlined in the two guidelines on safety and efficacy produced by FEDESA and the CVMP.