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What's New

The ICH E8(R1) Guideline reaches Step 4 of the ICH Process

The ICH E8(R1) Guideline on General considerations for Clinical Studies reached Step 4 of the ICH Process on 6 October 2021.

Clinical studies of medicinal products are conducted to provide information that can ultimately improve access to safe and effective products with meaningful impact on patients, while protecting those participating in the studies. ICH E8(R1) provides guidance on the clinical development lifecycle, including designing quality into clinical studies, considering the broad range of clinical study designs and data sources used.

This modernisation of ICH E8 is the first step towards the Renovation of Good Clinical Practice initiated in 2017. The revision incorporates the most current concepts achieving fit-for-purpose data quality as one of the essential considerations for all clinical trials. 

 

 

New Training from Brookwood Global - Essential Guide to the EU Clinical Trial Regulation Online Training

This online, on-demand course covers the main content and requirements of the EU Clinical Trial Regulation 2014 No. 536 (the CTR).

Implementation of the CTR starts on 31 January 2022. Sponsors will have the option of starting trials in accordance with the CTR from this date. It is important that both sponsors and investigators are aware of the changes and new requirements.

Our course is interactive and has both narrated and read-only options. The course is personalized using participants name.

At the end of the course participants are able to print a certificate of completion for their training records.

The course is delivered using Brookwood’s Articulate Rise learning management platform. This allows participants to set their own password and access their training dashboard. We are able to track activity and provide progress and completion reports to the training organizers.

Alternatively, the course can be provided to organizations under license as Scorm files to be delivered on their own learning management system.

 

Brookwood launches inspection readiness training.

We are pleased to announce the launch of our inspection readiness training “Are you ready for … a GCP inspection”.

This online, on-demand training is available 24/7/365. It has been developed with those experienced in the area and is based on questions that you may like to have answered relating to inspections. It provides great tips, words of advice and practical help for those wanting to know more about an inspection that they may face. 

 

British Ambassador to Bulgaria opened Brookwood webinar on 2 July 2020

Her Majesty the Queen’s Ambassador to Bulgaria, Emma Hopkins, opened Brookwood Global’s webinar for senior members of pharma and biotech industries in CEE countries on 2 July 2020. Guests have been invited by the UK’s Department of International Trade in Poland, Bulgaria, Romania and Slovakia. In addition to learning more about ‘Brookwood’s history and products, participants will be treated to a presentation by Prof Dr David Hutchinson on the challenges facing clinical research now and in the period post-pandemic. This will be followed by a discussion on the impact of the pandemic on clinical trials in the region, by Laszlo Pop of Precision for Medicine, Brookwood’s trading partner in the region.

 

British Ambassador opens Brookwood webinar on 28 May 2020

Her Majesty the Queen’s Ambassador to Denmark, Dominic Schroeder, opens Brookwood Global’s webinar for senior members of Denmark’s pharma and biotech industries on 28 May. In addition to learning more about ‘Brookwood’s history and products, participants will be treated to a presentation by Prof Dr David Hutchinson on the challenges facing clinical research now and in the period post-pandemic. This webinar follows a successful breakfast meeting hosted by the Ambassador at the British Embassy in Copenhagen last October.

 

Masters in high quality online training

Brookwood Global has an outstanding range of online training courses in GCP, PV, GDPR, NIS, GCLP and data management, for sponsors and investigator sites. Our key GCP course for investigator sites is available in 14 languages! Our sponsor range forms an ideal corporate training program.

See our new e-brochure for details of all courses. Click the video link to see a sample.
https://brookwood-global.com/Books/Online-Training-Brochure/

 

Safety reporting for the investigator site

Our new course for the investigator site outlines their safety reporting responsibilities. Want to evaluate it?
Just ask .. email info@brookwood-global.com

 

Bespoke training courses for you

Let us take your ideas and content and turn them into an interactive online training course. We have the skills and experience. Talk to us about your needs. We will be able to help! Email info@brookwood-global.com

 

Keep up to date … Advisor newsletter and our Twitter page

Our 20 issue per annum Advisor newsletter keeps busy clinical research professionals up-to-date with the latest news on regulations, guidelines and news stories of relevance to a global clinical research environment. We summarise key guidance and provide links to the resources. Electronically delivered, you can read it anywhere, anytime to suit your schedule. A wide range of subscription options is available.

See a recent issue … https://brookwood-global.com/Newsletters/Advisor456/

 

You can keep up to date between issues with our Twitter page @GCPadvisor

 
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