Understanding the regulatory aspects that impact the use of technology
Technology has allowed us to reimagine the way clinical trials are conducted. By shifting some – if not all – data collection away from study sites, it’s possible to improve participant access, reduce the burden on investigators, and increase trial efficiency. The decentralised clinical trial approach is gaining such popularity that all pharmaceutical companies and clinical research organisations (CROs) surveyed in a McKinsey’s Clinical Operations Roundtable expected virtual trials to be a major component of their portfolios and 89 percent they expected to run a trial with most activities in participants’ homes.
Join ICON for the second in the series where we explore the regulatory and legal aspects behind the technology applied in decentralised clinical trials.
The participants will learn the following during the presentation:
The aspects of technology in the ecosystem enabling decentralised clinical trials
- Managing regulatory compliance in data flow and interoperability
- Ensuring cyber security to minimise risks
Equity, inclusion and diversity in clinical trials
- Removing the barriers of the digital health divide
- Review and discussion on recent FDA guidance and ICH ethnicity guidance
eConsent
- Global and regional regulatory compliance and acceptance
Digital medicine in clinical – Digital Health Technologies (DHTs, e.g., digital wearables and sensors)
- Application options and suitability
- Implications of regulatory guidance on digital endpoints and digital health technology
- Requirements for DHTs use in clinical trials and understanding the differences in medical grade, health and wellness DHTs
Considerations in the use of telehealth deployment in decentralised clinical trials
- Aligning with standard of care and respecting prevalent cultures
- Security and data privacy requirements
- Overview of telehealth regulatory landscape
Jo Hulbert
Ms Hulbert has 25+ years of regulatory experience. Since joining the industry, she has gained in-depth experience in the areas of regulatory affairs, product development, clinical trials, pharmacovigilance, and quality assurance (GCP, GVP, IP-GMP and regulatory). She specializes in managing all regulatory aspects of global clinical trials and MAAs and provides a broad range of strategy and consultancy for pharmaceuticals, biologicals, medical devices, and advanced therapies, with a special interest in innovation, DCTs, and transformation. Ms Hulbert has worked in a variety of therapeutic areas and technologies ranging from known active products to biological and advanced therapy medicinal products (ATMPs)/genetically modified organisms (GMOs) and from oral dosage forms to topicals and transdermals.
Professionals in the following areas in the pharmaceutical, biotech, medical device or CRO spaces:
- Clinical Development
- Project Management
- Clinical Operations
- Procurement
- Outsourcing
- Strategy and Innovation
- Protocol Development
- Patient-Centric Innovation
- Business Operations
- Data Management
- Scientists and Biostatisticians
- Decentralized Clincal Trial Operations
- Clinical Science
- Outcomes research
- Clinical trial planning and optimization
- Medical Affairs
- Patient-centric innovation