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Training courses & Webinars:
Clinical

 

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

Clinical Evaluation of Medical Devices: The Clinical Evaluation Report

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

Presented by Janette Benaddi (bio)

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Clinical Quality Management Systems Training Course

Clinical Quality Management Systems

18-19 Nov 2021 - Online webinar
Also on: 26 May 2022

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

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.

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 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.

Presented by Laura Brown (bio)

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

EU Clinical Trial Regulation: Overview and Implementation

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

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

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

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

7-8 Oct 2021 - Online webinar
Also on: 17 Jan 2022

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

8-9 Nov 2021 - Online webinar
Also on: 9 May 2022

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

Presented by Janette Benaddi (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

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.

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

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.

Presented by Julian Braidwood (bio)
Donna Taylor (bio)
Marie-Pascale Tiberghien (bio)

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Very well organized in terms of content, very well presented, replies for every single question is addressed by the wonderful speaker and I truly enjoyed it and learned so much. Thank you it was excellent!

Nurit Birenboim, Regulatory Affairs Associate, Ayala Pharmaceutical

Janette is very nice and friendly. She has a lot of relevant knowledge and experience about the clinical evaluation process and the report. I learned a lot form her!

Dror Sever, Senior Device Information Scientist, Novo Nordisk

I thought this was a terrific webinar, lead by an excellent topic expert, and I feel much more confident about participating and/or leading the CER update at my company.

Juliana Pugmire, Clinical Research Consultant, Current Health

I found the details provided in the webinar and the additional resources/notes were very comprehensive. I enjoyed that there were multiple speakers/subject matter experts for specific areas in GCP planning to allow for better understanding of the key stakeholders in the planning process. The speakers were very informative and topics discussed were very relevant. The transition between topics kept attendees engaged for the entire time.

Abigail Harwood, Advisor Brand Maximization, Elanco New Zealand

This was a very detailed and great overview of the CTR and I would recommend following this course if this new CTR has impact on your work or your company.

Leyla Nematollahi, Regulatory Affairs Liaison, Galapagos

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

Very interactive and stimulating.

Margherita Lerro, Study Manager, Menarini Ricerche

It was overall a very good webinar that gave a nice overview of the Clinical Evaluation proces. A shame it had to be a webinar due to the Covid-19 situation, it would have worked better if we could all meet in person and also have small conversations in breaks and so on.

Christina Frary, research audiologist, Demant

I think overall the webinar very good, instructive and informative.

Ban Eshqi, Scientific Affairs Pharmacist, CHEMIDEX PHARMA LTD

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

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