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Are you GDPR ready?
Since its beginning, the pharmaceutical industry has used and depended on personal data.
Under the new GDPR, this data is subject to higher standards of protection since much of the data utilised is considered ‘sensitive personal data’. The implementation of GDPR is intended to harmonise data privacy laws across Europe and provide greater data protection rights to the individual, which will introduce stricter provisions for the pharmaceutical industry; particularly in clinical trials and pharmacovigilance. GDPR brings with it serious implications for non-compliance and therefore, in such a heavily regulated industry, it is crucial to understand how to follow the correct methods of compliance. Attendees will have the opportunity to cement this knowledge through interactive case studies.
This course can also be taken as part of a 3-day course including 2 days on Regulatory Affairs for Clinical Trials, find out more about this in-depth course here.
The course is complemented with a series of case studies related to data handling processes in line with GDPR compliance
Sumaiya Patel
Sumaiya Patel is a director of a regulatory consultancy with over 11 years’ experience in both pre and post-approvals for generic, CRO and big pharma organisations. Sumaiya has experience in regulatory implementation and training, focusing on CMC, clinical development, strategy and manufacturing. She has extensive experience in writing Module 3 of CTD, Module 2 of the CTD and also Quality Expert statements to support dossiers and Type II Quality variations. She has a track record of providing regulatory inputs related to CMC aspects during the development product lifecycle.
The course is relevant for anyone working in clinical research who could benefit from an in-depth understanding of the data protection laws and their implementation, those who are in a position with the responsibility of managing data within clinical or regulatory affairs, and those who are regulatory affairs professionals in the pharmaceutical industry.
Risk Management in Clinical Outsourcing
Managing risk is essential in good oversight of a clinical trial. In this webinar, the following points were discussed:
• Risk Management for Outsourcing
• Risk Identification
• Risk Impact Mitigation through Risk Management
• Risk Management Plan
This session was led by Julianne Hull. Julianne has successfully held global leadership roles in vendor management/outsourcing and clinical operations for several large and medium pharmaceutical companies (Pfizer, Wyeth, Marion Merrell Dow, Biogen Idec and Ipsen).
23 Mar 2020 - 24 Mar 2020
Radisson Blu Edwardian Grafton, London
13 Nov 2019 - 14 Nov 2019
Radisson Blu Edwardian Grafton, London
2020 Dates TBC
Radisson Blu Edwardian Kenilworth, London
05 Nov 2019 - 06 Nov 2019
Radisson Blu Edwardian Grafton, London
2020 Dates TBC
Radisson Blu Edwardian Grafton, London
09 Mar 2020 - 10 Mar 2020
Radisson Blu Edwardian Kenilworth, London
Next intake begins 4 November 2019
Online Academy
01 Jan 2020 - 01 Jan 2020
Radisson Blu Edwardian Grafton, London
02 Dec 2019 - 04 Dec 2019
Radisson Blu Edwardian Grafton, London
Dates TBC for 2020
Radisson Blu Edwardian Grafton, London
04 Dec 2019 - 05 Dec 2019
Le Palais Art Hotel Prague
19 Nov 2019 - 21 Nov 2019
Radisson Blu Edwardian Grafton, London
2020 Dates TBC
Radisson Blu Edwardian Grafton, London
10 Feb 2020 - 11 Feb 2020
Radisson Blu Edwardian Grafton, London
25 Mar 2020 - 26 Mar 2020
Radisson Blu Edwardian Grafton, London
21 Oct 2019 - 23 Oct 2019
Radisson Blu Edwardian Grafton, London
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