About The Course
From medical research, clinical trials to pharmacovigilance, the pharmaceutical industry is heavily dependent on patient-centric data, and as a result, the requirement to ensure compliance with privacy regulations goes beyond the responsibility of those in charge of data security.
Essential to pharma sponsors, CROs, CMOs and distributors, this seminar offers thorough analyses of data protection enforcement principles – including GDPR – and the impacts on various activities and departments. Through reviewing potential exposures, you will examine compliant practices including patient data collection, processing, transferring, anonymisation, de-identification. Important compliance policies & strategies to be discussed include data protection impact assessments, storage & security, contract & vendor management, breach notification procedures and legal proceeding.
Key Learning Outcomes
- Key objectives of GDPR, HIPAA, CPPA and impacts on healthcare & pharma sectors
- Principles of personal data processing and rights of data subjects
- Clinical operations and compliance with GDPR/FDA/EMA/GCP standards
- Data anonymisation and pseudonymisation processes in clinical operations
- Data protection impact assessments
- Develop data handling processes in line with GDPR compliance
- GDPR applications in adverse event reporting and patients’ privacy notice
- Interplay between GDPR and CTR (Clinical trial regulations)
- Data privacy compliance on Marketing and HCP engagement
- Non-compliance, privacy breaches and proceeding
- GDPR compliance & vendor management
Live Online Learning
Stay Home. Skill Up!
The current Covid-19 pandemic has put strains on various areas of business, especially when it comes to deriving commercial value from new initiatives. During this phase of self-isolation and working from home, we can help you meet your professional development needs and you can still take your professional development plans to the next level.
To support your learning goals we have converted our face-to-face trainings to LIVE Online Sessions. This way you can continue to attend live and interactive training sessions within the virtual classroom space where you can see and speak, with your Subject Matter Expert and other participants.
Benefits of Live Online Learning
Aimed at offering you immediate, high-quality practical information whilst minimising time and expenditure associated with travelling, our digital training platform enables you to interact in real time with course directors and remotely network with your fellow participants.
- Classroom Experience: Progress with fellow participants as you would in an on-site class
- Guaranteed cost-effectiveness: Travel budget saving, plus 20% price advantage for online participation
- Controlled environment with speakers managing the Q&A and discussions and tools for enhanced interactions
- Module-based approach to effectively manage your time and revisions
- Earn your Digital Certification and broadcast your achievements to your peers
- Onboarding: Available for all attendees
- Proven and secure training platform
Partner, Dewallens & Partners,
An has over 20 years’ legal experience specialised in pharmaceutical & medical law. Her core practice includes data protection & privacy legislation (especially GDPR) and healthcare ICT. She has an international reputation on the protection of health-related data. Her experiences include:
- Advising pharmaceutical, CRO, biotech, medtech companies and healthcare institutions on data protection especially in clinical trials and electrical health records
- Lecturing Medical Law at Ehsal Management School, Brussel
- Authored a variety of publications on various aspects of health law including “The electronic medical file. Practical and legal issues”
Upon completion of this training course, participants will earn a digital badge.
Attend and participate in the 2 full days of training course duration, led by the designated training expert
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.