Insight Series: Regulatory and Clinical Validation
This panel will provide practical insights from experienced operators and experts on how to navigate regulatory pathways efficiently, avoid common setbacks, and plan for compliance from day one.
Clarify your regulatory pathway: Understand how your solution moves through clinical validation, regulatory review, and compliance requirements and what that means for timelines and resources.
Anticipate risks and avoid delays: Learn common pitfalls that slow down validation and approval, and how to proactively mitigate them.
Execute with the right partners: Gain best practices for planning pre-clinical and clinical studies and effectively working with consultants and CROs to accelerate progress.
Speaker Highlight
Speaker Name: Alethea Wieland
Expertise: An expert in life sciences specializing in regulatory strategy, clinical operations, and corporate compliance for the development of drugs, biologics, and medical devices.
LinkedIn: https://www.linkedin.com/company/clinical-research-strategies/posts/?feedView=all
2. Speaker Name: Jeremy Kimmel
Expertise: An expert in bioengineering and medical technology leadership, specializing in the development of high-fidelity clinical simulations and strategic technical training for the medtech industry.
LinkedIn: https://www.linkedin.com/in/jeremydkimmel/
3. Speaker Name: Adam Butchy
Expertise: Co-founder of HEARTio and Forbes 30 Under 30 honoree, specializing in the intersection of Deep Learning and Cardiovascular Diagnostics to automate the detection of coronary artery disease."
LinkedIn: https://www.linkedin.com/in/adambutchy/