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Validity : 01st Aug'25 to 11th Aug'25
Digital Therapeutics (DTx) Regulatory Pathways
- Approval routes
- Real-world evidence
- Integration with clinical care
Overview of the webinar
- Digital Therapeutics (DTx) are clinically validated software-based interventions used to prevent, manage, or treat medical conditions. Unlike wellness apps, DTx products require regulatory approval, clinical evidence, and adherence to safety standards.
- This session explores the evolving regulatory landscape for DTx, including global frameworks such as the FDA, EU MDR, and emerging Indian guidelines under CDSCO and NDHM. It will cover approval processes, risk classifications, evidence requirements, and reimbursement considerations.
- Ideal for startups, pharma leaders, clinicians, and investors, the session will help you understand how to navigate regulatory complexities, bring DTx products to market compliantly, and stay ahead in this rapidly growing healthcare domain.
Who should attend?
- Digital Health Product Manager
- Regulatory Affairs Manager – HealthTech
- Chief Innovation Officer
- MedTech/HealthTech Founder or CEO
- Clinical Research Lead – Digital Health
- Head of R&D – Pharma or Biotech
- Quality & Compliance Manager
- Medical Affairs Director
- Digital Therapeutics Strategist
- Health Policy & Access Specialist
- Clinical Validation Scientist
- Chief Medical Officer (CMO) – Digital Health
- Health Technology Assessment (HTA) Analyst
- Digital Health Investment Analyst
- Software as a Medical Device (SaMD) Specialist
Why should you attend?
- Understanding the regulatory landscape becomes crucial for innovators, healthcare professionals, and policymakers alike. This session is designed to demystify the evolving regulatory frameworks governing DTx-covering approvals, clinical validation and global best practices
- Attending this session will help you avoid common pitfalls, and align with current and future compliance expectations
- It’s an opportunity to stay ahead in one of the fastest-growing segments of healthcare—where technology meets therapeutics-and ensures your innovation reaches patients legally, safely and effectively
Faculty - Dr.Sonali Kirde
Dr. Sonali Kirde is a Medical Doctor and Strategic Consultant with rich experience in the pharmaceutical industry, having held critical roles at Merck Sharp Dohme (MSD), GlaxoSmithKline (GSK), and Takeda Biopharmaceuticals. Her expertise includes clinical pharmacology, regulatory strategy, market access, and medical affairs, driving impactful product launches and healthcare innovations.
As CEO & Founder HealthSpect 360, she support healthtech startups on regulatory, GTM, and investment strategy. She is also the Founder of ELEVATE, where she mentors doctors for leadership roles, exploring non-traditional career opportunities specially in Pharmaceutical companies. She also consults healthtech startups on regulatory, GTM, and investment strategy. In addition, she runs a Podcast Channel- The HealthSpect Show where she share powerful insights, tips, and real conversations—from basics to bold innovations in healthcare and startup ecosystems.
Dr. Sonali is a mentor and judge at top incubators including Startup India's MAARG, BHASKAR, IIT Bombay E-Cell, IIT Madras E-Cell, AIC Pinnacle, WISE SNDT, MSSU I-SPARK, VentureBlick (Singapore), GooCampus, Womennovator, WIMA, and Wadhwani Foundation, and serves as Regional Director for a nonprofit supporting girl child education and women’s empowerment.
As a recognized speaker, she have been invited to share her insights at national and international forums, contributing to discussions on healthcare innovation, patient outcomes, and medical advancement.
As a Consultant to health care startups, she plays a vital role in the growth and success.