The revised Good Clinical Practice (GCP) guideline from the International Conference on Harmonisation (ICH), known as ICH-GCP E6(R2), has now been approved. This first update in two decades is expected to be adopted worldwide by regulatory agencies, including the FDA, EMA and Japanese Health Authority, and so brings major implications for all clinical development stakeholders.
ICH-GCP E6(R2) reflects the industry’s growing emphasis on risk-based quality management, highlighting the increasing complexity of clinical trials and how the ongoing evolution in technology creates opportunity for greater efficiency in quality management – specifically describing quality management as multi-faceted, with an emphasis on re-imagining protocol design to minimize complexity, unnecessary procedures and related data collection key to better decision making.
This one hour webinar follows on from the successful December 2016 session on ‘Remote Monitoring and Preparing for ICH-GCP E6(R2) at Investigator Sites’ (archive recording available here), which detailed and discussed what was changing from the perspective of an investigator site. Many participants requested an additional session to address further questions they now have as they prepare for future GCP audits and inspections conducted in accordance with these revised guidelines so this webinar will address pre-submitted questions.
Intralinks is also thrilled to welcome Gunnar Danielsson and his viewpoint as a retired GCP Inspector. For over a decade, Gunnar conducted countless inspections on behalf of the Swedish Medicines Agency and the European Medicines Agency (EMA). He was an active member of EMA GCP Inspectors Working Group where he had direct involvement in the development of a variety of guidelines and reflection papers.
Andrew Mitchell, Director of Life Sciences, Intralinks
Andrew Mitchell has almost 20 years of experience delivering software to the pharmaceutical industry and has been on the forefront of driving key innovation such as the adoption of EDC and Electronic Safety Reporting (E2B). His career includes positions at Covance, Relsys, Medidata, and he led the EU Drug Safety Practice at BioPharm prior to joining Intralinks where he’s responsible for the Life Sciences vertical, regularly speaking and writing on topics related to biopharma deal making, clinical collaboration and drug safety.
Dan Sfera, The Clinical Trials Guru
Dan Sfera has owned and operated clinical research sites since 2005. In 2010 Dan decided to get into blogging about clinical research in order to generate more business for his clinic as well as to attract potential study participants to his existing studies. Soon he discovered that the majority of the audience members were actually other clinical research professionals who were taking to the internet to try and learn more about the industry. His blog became a place to demystify clinical trials and help other research companies accomplish their business objectives by creating practical solutions to their real world problems.
Gunnar Danielsson, DGD Consulting
Gunnar Danielsson has +25 years of clinical research experience within the pharmaceutical industry, he has held positions covering monitoring, project leadership and auditing as well as process implementation. This includes over a decade (2003-14) at the Swedish Medical Products Agency as the GCP Inspector where he conducted a vast number of local and international inspections. Gunnar was also an active member of EMA GCP Inspectors Working Group and had direct involvement in the development of a variety of guidelines and reflection papers.
Having retired from the Agency, he is now working as an independent consultant and regularly gives lectures and presentations to industry and academia.
Who Should Attend?
Clinical Trials professionals, including:
- Clinical Site Selection/Management Personnel
- Clinical Site Coordinators (CRCs)
- Clinical Research Associates/Monitors (CRAs)
- Clinical Trial Managers (CTMs)
- Data Managers
- Clinical Operations & Project Management
- Compliance & Regulatory Affairs
Intralinks has established itself a household name in the life sciences and financial services worlds over its 20-year history with over 4.1 million business users having used its secure, cloud-based platform, and 99% of Fortune 1000 companies among its customers. To date, Intralinks has supported over $31 trillion in high-stakes transactions, making the company a clear leader in the enterprise content collaboration market – and with over 2,100 active clinical trials and +40,000 investigator site users, is a trusted solution for managing clinical and safety-related content.
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