Live Online Training Course | 9:30am - 5pm GMT
Live Online Training Course | 9:30am - 5pm GMT
Master The Regulatory Affairs Landscape For Clinical Trials
Discuss and benchmark with clinical experts in a dedicated course designed to help you ensure efficient regulatory and inspection compliance
Deep dive into various niche areas such as ethics committee approval, paediatrics, data protection and much more…
Course Overview
This immersive 2-day training course provides you with all the essential regulatory and guideline expertise and updates to run a clinical trial from start to finish; including Inspection and pharmacovigilance.
Through a combination of theory and discussion sessions, this course will help you understand current regulations as well as upcoming legislation to be implemented in the clinical trials space.
Master submitting to the clinical trials information system (CTIS). Prepare for regulatory inspection. Deploy good clinical and manufacturing practice. Do all of this and more in the EU and considerations for the US.
Live Online Training Course
Gain real-time access to a subject matter expert delivering online training in a structured virtual classroom environment.
Over this live online course students will learn through:
- Direct interaction with the trainer during live sessions
- Participation in interactive features within sessions including polls, Q&A and break out room discussion
- Pre-course reading materials, and day 1 evening reading materials
- Interaction with peers during live sessions and through the online forum
Timings and dates are subject to change - final confirmation will be provided with login details. Delegates will receive login instructions 2 working days prior to the course start date. If you have any questions please contact Katie.Condon@Informa.com
What Will You Learn?
Run Compliant Clinical Trials With Detailed ICH GCP, GMP And EU CTR Know-How
- Learn current and future pharmaceutical trial legislation
- Gain an in depth understanding of ICH GCP and all necessary compliance requirements
- Get to grips with the main challenges of the EU CTR implementation
Break Down Regulatory Affairs Silos with Expert Insight
- Discuss the new Clinical Trial Information System (CTIS)
- Gather the importance of data protection and informed consent requirements
- Deep dive into pharmacovigilance, paediatric trials, and regulatory inspections
Deepen your Clinical Regulatory Affairs Knowledge
- Uncover the requirements for the EMA
- Gain applicable skills to bolster your career as a regulatory professional
- Become a specialist in running compliant clinical trials and applications
Meet Your Course Leader
Laura is Chairman of an International Pharmaceutical Management Consultancy and Course Director for the MSc in Regulatory Affairs, TOPRA and University of Hertfordshire.
Laura has extensive experience in senior management roles in the pharmaceutical industry and has worked for several pharmaceutical companies including GSK, Hoeschst Marion Roussell and Phoenix International and consulted internationally with numerous pharmaceutical companies in the EU, US, Singapore, China and India.
Who is this course for?
This course is intended for clinical & medical affairs professionals working within biotechnology and pharmaceutical companies. This includes those working in the following areas:
- Clinical Development
- Clinical Operations
- Clinical Project Management
- Clinical Research
- Clinical Trials
- Clinical Study Managers
- Clinical Submissions/Disclosure/Transparency
- Plain Language Summaries Manager