Online training during Covid restrictions - our programes continue this spring in online webinar format

Training courses & Webinars:
Clinical

 

Clinical Evaluation of Medical Devices: The Clinical Evaluation Report Training Course

Clinical Evaluation of Medical Devices: The Clinical Evaluation Report

8-9 Jun 2021 - Online webinar
Also on: 29 Nov 2021

Cover all the aspects of clinical evaluation in line with the European medical device regulations and applicable guidance documents

Presented by Janette Benaddi (bio)

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Clinical Quality Management Systems Training Course

Clinical Quality Management Systems

17-18 May 2021 - Online webinar
Also on: 18 Nov 2021

A two-day course that will ensure you comply with new regulatory requirements.

Presented by Laura Brown (bio)

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Clinical Trial Regulatory Requirements Training Course

Clinical Trial Regulatory Requirements

5-6 Jul 2021 - Online webinar

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.

Presented by Laura Brown (bio)

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Data Integrity and Document Management Training Course

Data Integrity and Document Management

4 Oct 2021 - Online webinar
Also on: 5 Oct 2021

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.

Presented by Laura Brown (bio)

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Drafting and Negotiating Clinical Trial Agreements Training Course

Drafting and Negotiating Clinical Trial Agreements

10 Jun 2021 - Online webinar
Also on: 4 Nov 2021

This intensive and interactive one-day programme focuses on CTAs in the pharmaceutical industry where legal, policy and ethical considerations underpin how these agreements are drafted

Presented by Alex Denoon (bio)
Richard Dickinson (bio)

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EU (European Union) Clinical Trial Regulation: Overview and Implementation Training Course

EU Clinical Trial Regulation: Overview and Implementation

22-23 Apr 2021 - Online webinar
Also on: 18 Oct 2021

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

Presented by Laura Brown (bio)

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GCP (Good Clinical Practice) and Clinical Research Update - Hot Inspection Topics Training Course

GCP and Clinical Research Update - Hot Inspection Topics

22 Sep 2021 - London
Also on: 24 Sep 2021

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

Presented by Laura Brown (bio)

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Managing Vendor/CRO (Contract Research Organisation)/CMO (Contract Manufacturing Organisation) Oversight Training Course

Managing Vendor/CRO/CMO Oversight

26-27 Apr 2021 - Online webinar
Also on: 7 Oct 2021

Learn how to prepare a Request for Proposal (RFP), evaluate and select the right CRO and establish procedures for vendor oversight for R&D projects you need to outsource

Presented by Laura Brown (bio)

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Medical Device Studies: Clinical Evidence Training Course

Medical Device Studies: Clinical Evidence

10-11 May 2021 - Online webinar
Also on: 8 Nov 2021

Gathering and using clinical evidence for CE marking and post-market compliance in line with the new MDR

Presented by Janette Benaddi (bio)
Robin Stephens (bio)

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Medical Device Studies: Regulatory Requirements and Adverse Event Reporting Training Course

Medical Device Studies: Regulatory Requirements and Adverse Event Reporting

20-21 Sep 2021 - London
Also on: 22 Sep 2021

An essential overview of medical device clinical evaluations, clinical investigations, post-market clinical follow-up requirements and adverse event and vigilance reporting.

Presented by Janette Benaddi (bio)

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Practical Implementation of GCP (Good Clinical Practice) in Veterinary Field Studies Training Course

Practical Implementation of GCP in Veterinary Field Studies

27-28 Apr 2021 - Online webinar
Also on: 26 Oct 2021

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.

Presented by Julian Braidwood (bio)
Sue Lester (bio)
Marie-Pascale Tiberghien (bio)

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Would highly recommend this course to in-house lawyers.

Zera Ong, Commercial Associate, Evox Therapeutics

The overall webinar was informative and easy to follow and understand. Would highly recommend to anyone who has an active role in vigilance or clinical activity processes at your company. Jannette is a wonderful speaker, who is very articulate in putting things simply, but effectively without losing any necessary detail.

Hannah Vince-Drew, Clinical Research Associate, Bedfont Scientific

Great presentation!

Alina Cezar, Project Coordinator, University of Cambridge

Everything was perfect.

Amnah AlKhan, Medical Devices Engineer, Gulf Health Council

This webinar explained very well the complex matter of DI. Very engaging.

Serena Di Molfetta, Study Manager, Menarini Ricerche S.p.A.

The speakers appear to be passionate about the topic and the adjacent fields. Gave good insight in relevant cases and practice.

Martin de Vlaming, Legal Counsel, Erasmus MC

The content touched upon the most relevant parts of a clinical trial agreement, the presentation was good and the speakers knowledge and expertise also gave me more insight in the practical side of clinical trial agreements.

Angela Paltan, Legal counsel, Erasmus MC

The group discussion workshop was very intriguing to hear to peoples perspective and experiences.

Hema Sivasubramanian, Clinical Research Coordination Assistant, National University of Ireland, Galway

Laura was engaged the whole time and really made the presented topics interesting. She also clearly has a wealth of knowledge within the area, so could answer any questions. I liked that even though the course was online it was possible to have breakout into groups with participants talking and discussing together.

Anna Olevik, Regulatory Affairs Manager, Camurus AB

Very good course! It worked very well to have it online and be able to see the speaker and the presentation at the same time!

Christa Myhre, RA Specialist, Radiometer Medical Aps