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overview
About The Webinar:
Executing a clinical trial project entails multidisciplinary, cross-functional collaborations and among the most pressing challenge is overcoming the complex web of regulatory requirements.
To help you enhance risk mitigation in drug development, this webinar delves into critical legal & regulatory aspects underpinning clinical trials globally. Key takeaways will include the impacts of Covid-19 and the use of technology on clinical project compliance strategies. You will also build a practical checklist for regulatory risk assessment encompassing data protection & integrity and financial transparency.
Key Takeaways:
- Conducting & monitoring clinical projects during Covid-19: Global regulators’ recommendations
- Covid-19 Regulators’ emergency vaccine approval procedures, urgent importations, fast-track approval process (ie. FDA, EMA, China, etc)
- Important legal/regulatory amendments:
- Data Protection and Data Integrity
- Financial Transparency
- Multi-country trials
- CTA amendments
- The use of RWE in regulatory process
- Digital design for Clinical Trials
- Regulatory Considerations with Technology Use in Clinical Trials
Expert Guest Speaker
Dr. Salma Michor (PhD, MSc, MBA, CMgr, RAC-Treasurer), CEO, Michor Consulting
Salma has advised numerous global clients across Pharmaceutical, Medical and Food industries, including J&J, Novartis, Pfizer and Shire and many more.
She had previously worked for Torrex-Chiesi (Chiesi Farmaceutici S.p.A); Wyeth Whitehall Export, and Croma Pharma GmbH and had been the Director of Global Supporting Operations – Medical Devices and Pharmaceuticals (Ophthalmology & Orthopedics) where she was in-charge of technical and leadership of four departments – including Regulatory Affairs and Compliance; Medical and Vigilance; Change Control and Life Cycle Management; as well as Packaging and Pharmaceutical editing. Her duties included overall leadership & personnel management, budgeting and strategic planning, liaison with external contractors, doctors and customers in 60 countries worldwide. Here she also gained first-hand experience with submission of clinical trials phases: I-III as well as turnaround management of post-Mergers and Acquisitions integration operations.
Her experiences include:
- Post-acquisition phase-out and closedown after M&As
- Managing DCP registrations
- Consolidation of Multi-language labelling texts for pharmaceutical products and medical devices
- Forming clinical and registration strategies for medicinalproducts (combination, generics)
- Labelling compliance for drugs & food supplement
- Authoring CMC sections for drug products or drug/devicecombination products
- Preparing pharmaceutical and medical device companiesfor internal and FDA audits
- Managing large company-wide compliance projects (CAPA, GMP, ISO, etc)
- Preparing companies in 3rd countries for EMA, MHRA and AGES inspections and managing the whole biotech registration and clinical testing in the EU
Online Learning seminar
There is also a Live Online seminar for Regulatory Affairs for Clinical Trials.
Date: 30 June – 3 July 2020
Time: 1:00pm-5:00pm (SGT)
Key Learning Outcomes
- Legal aspects underpinning clinical trials (globally and Asian region): Data Privacy and
- Integrity, Ethical Principles, Financial Transparency and Authorisations
- Important and amended regulations in clinical trials and how they affect study designs & protocol
- Risk-based quality management in clinical trials especially for Asia
- Key considerations in use of technology in clinical trials
- Develop effective study designs for multi-country clinical programmes
- Regulatory risk assessment and mitigation
- Best practices in inspection preparation
- Case studies of protocol deviation, violations and prevention
when & where
20 May 2020
This event is a free webinar. Limited seats, registrations are on first-come-first-served basis.
On-site & in-house training
Deliver this course how you want, where you want, when you want – and save up to 40%! 8+ employees seeking training on the same topic?
Talk to us about an on-site/in-house & customised solution.