- Next: 28-29 Nov 2022 Live online
- Also: 27 Feb-2 Mar 2023 Live online
- Also: 4-5 May 2023 Live online
- + 2 more
Clinical Evaluation of Medical Devices: The Clinical Evaluation Report
Live online, Classroom
Focused
Cover all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance documents
- 12 CPD hours
-
Presented by Ms Janette Benaddi
- Next: 17-18 Nov 2022 Live online
- Also: 16-17 Mar 2023 Live online
- Also: 6-7 Jul 2023 Classroom
- Also: 16-17 Nov 2023 Live online
Clinical Quality Management Systems
Live online, Classroom
Focused
A two-day course that will ensure you comply with new regulatory requirements.
- 12 CPD hours
-
Presented by Dr Laura Brown
- Next: 2-3 Feb 2023 Live online
- Also: 5-6 Jun 2023 Live online
- Also: 9-10 Oct 2023 Live online
Clinical Trial Monitoring
Live online
This course will assure monitors understand the importance of compliance with GCP standards, and how these apply to monitoring clinical trials including during the pandemic and in the future.
- 12 CPD hours
-
Presented by Dr Laura Brown
- Next: 23-24 Jan 2023 Live online
- Also: 25-26 May 2023 Classroom
- Also: 21-22 Sep 2023 Live online
Clinical Trial Regulatory Requirements
Live online, Classroom
Focused
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 key difference it compares with the Clinical Directive requirements.
- 12 CPD hours
-
Presented by Dr Laura Brown
- Next: 10 Oct 2022 Live online
- Also: 21 Apr 2023 Live online
- Also: 24 Jul 2023 Classroom
- Also: 1 Dec 2023 Live online
Data Integrity and Document Management
Live online, Classroom
Focused
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.
- 6 CPD hours
-
Presented by Dr Laura Brown
- Next: 20-21 Oct 2022 Live online
- Also: 20-21 Feb 2023 Live online
- Also: 22-23 May 2023 Live online
- + 2 more
EU Clinical Trial Regulation 536/2014: Overview and Implementation
Live online, Classroom
Focused
This course will provide an essential understanding to help with compliance with the new regulation and associated implementing texts for carrying out clinical trials in the EU
- 12 CPD hours
-
Presented by Dr Laura Brown
- Next: 10 Mar 2023 Live online
- Also: 20 Jul 2023 Classroom
- Also: 24 Nov 2023 Live online
GCP and Clinical Research Update - Hot Inspection Topics
Live online, Classroom
Focused
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
- 6 CPD hours
-
Presented by Dr Laura Brown
- Next: 17-18 Oct 2022 Live online
- Also: 16-17 Jan 2023 Live online
- Also: 17-18 Apr 2023 Live online
- + 2 more
Managing Vendor/CRO/CMO Oversight
Live online, Classroom
Focused
Optimising oversight for inspection compliance
- 12 CPD hours
-
Presented by Dr Laura Brown
- Next: 24-25 Nov 2022 Live online
- Also: 20-23 Mar 2023 Live online
- Also: 12-13 Jul 2023 Classroom
- Also: 13-14 Nov 2023 Live online
Medical Device Studies: Clinical Evidence
Live online, Classroom
Focused
Gathering and using clinical evidence for CE marking and post-market compliance in line with the new MDR
- 12 CPD hours
-
Presented by Ms Janette Benaddi
- Next: 3-4 Oct 2022 Live online
- Also: 18-19 Jan 2023 Live online
- Also: 9-10 May 2023 Classroom
- Also: 18-21 Sep 2023 Live online
Medical Device Studies: Regulatory Requirements and Adverse Event Reporting
Live online, Classroom
Focused
An essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow-up requirements and adverse event and vigilance reporting.
- 12 CPD hours
-
Presented by Ms Janette Benaddi
- Next: 29-30 Nov 2022 Live online
- Also: 2-3 Mar 2023 Live online
- Also: 17-18 Jul 2023 Classroom
- Also: 27-30 Nov 2023 Live online
Practical Implementation of GCP in Veterinary Field Studies
Live online, Classroom
Focused
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.
- 12 CPD hours
-
Presented by Donna Taylor
-
+ 2 more
- Next: 29 Nov 2022 Live online
Update - Latest Position on the New UK Clinical Trial Proposals
Live online
High impact
‘Better regulation…for better trials…for better health’ The Medicines and Healthcare products Regulatory Agency (MHRA) have set far-reaching proposals to improve and strengthen the UK clinical trials legislation to make the UK the best place to research and develop safe and innovative medicines. This webinar will bring you up-to-date with the current position regarding the proposals and the potential implications and opportunities for the industry.
- 1.5 CPD hours
-
Presented by Dr David Jefferys