Drug Safety 2018 aims to discuss the latest findings and current thinking on pharmacovigilance. Importantly, it will address the newest regulatory updates and interpretations of them, including the impact of the vital and much awaited Clinical Trial Regulations.
- UPDATE: Clinical Trials of Investigational Medicinal Products (CTIMPS)
Legislation sets out how drug trials are approved, conducted, monitored and reported.
The NHS Health Research Authority have stated as of the 6th February 2018, future developments on the new regulation will:
- Harmonise the electronic submission and assessment process
- Improve collaboration, information-sharing and decision-making between and within EU Member States
- Increase transparency of information on clinical trials; and ensure the highest standards of safety for all participants in clinical trials
“Are preparing for the new Regulation while the UK is still an EU Member State, alongside working with partners to maximise the opportunities of different Brexit negotiation outcomes”
- NHS Health Research Authority*
This week’s spotlight features the MHRA:
Hear from the Medicines and Healthcare products Regulatory Agency (MHRA) as they discuss the latest updates to clinical trial regulations this June.
Below is a summary of their presentation:
UPDATES TO GLOBAL REGULATORY REQUIREMENTS
Spotlight Presentation – The Future of Clinical Trial Regulations
- Overview of the major changes that will be implemented in 2019
- Harmonising the assessment and supervision processes for clinical trials throughout the EU, via an EU portal and database
- Learn how the new regulations will increase the efficiency of all trials in Europe whilst avoiding unnecessary duplication
- Understand what this means for drugs currently in clinical trial pipelines
- Guidelines for applying the regulatory changes to current clinical trials
- A timeline of when these changes will have to be made by
Presented by: Kirsty Wydenbach, Deputy Unit Manager, Clinical Trials Unit, MHRA
Download the complete brochure online for all sessions and speaker line-up: www.drugsafetyconference.co.uk/wptpr
For those looking to attend there are currently early-bird rates available up to £400, for a limited time only!
Further information is available at: www.drugsafetyconference.co.uk/wptpr
SMi presents the5th conference on:
Drug Safety 2018
Date: 11th – 12th June 2018
Workshops: 13th June 2018
Location: Holiday Inn Kensington Forum, London UK
Source: * http://bit.ly/2AOgMIS
About SMi Group:
Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world’s most forward-thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk