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

28-29 Jan 2021 - Online webinar
Also on: 5 Jul 2021

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

5 Mar 2021 - Online webinar
Also on: 4 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

26 Feb 2021 - Online webinar
Also on: 10 Jun 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

23 Mar 2021 - Online webinar
Also on: 22 Sep 2021

This course provides an update on recent changes to ICH GCP R2, EU Clinical Trial Regulation and guidance and will discuss how these changes have been implemented

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

23-24 Feb 2021 - Online webinar
Also on: 20 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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Everything was perfect.

Amnah AlKhan, Medical Devices Engineer, Gulf Health Council

The training was PHENOMENAL and I have learned so much regarding various topics in the field.

Anthony Hugill, Clinical Safety Specialist, Novocure

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

Really informative.

Christina Schøier, Senior veterinarian, University Hospital of Companion Animals, University of Copenhagen, SUND

Good speakers. Too much content given the period of time.

Audur Thorisdottir, Study Director, VESO Vikan

It was a very good webinar especially due to Laura´s way of presentation. The balance between information given by Laura and the break-out sessions were really great.

Alexandra Ludvigsen, Senior Project Coordinator, Bavarian Nordic GmbH

Laura is a great mentor. All aspects were good.

Udaya Toti, Sr. Manager - Formulation Development, Renaissance Lakewood LLC

Janette was very knowledgable and enthusiastic and was able to keep the subjects interesting throughout the whole meeting. The content was very relevant.

Liselotte Borup, Clinical Trial Manager, Oticon Medical

The course gave me a good overview of the MDR and the reporting of adverse events: the content was good, the presentations were clear and the speaker was very good. She was open to questions, which she answered in the best way possible.

Valérie Jean, Senior Clinical Research Associate, Spineart SA

Laura was passionate, knowledgable and entertaining. I particularly liked the group work sessions, which gave us time to digest and use the information just obtained.

Josy Giordano, Regulatory Affairs Manager, Nestec SA