About us
ISO 14155 Training Program is being organised as part of the UP Health Tech Conclave 1.0 by UP Promote Pharma Council in association with AIMED and Cliniminds..
UP Promote Pharma Council is a Section-8 not-for-profit company established to strengthen and promote pharmaceutical research and innovation in the state. Headquartered in Lucknow, Uttar Pradesh, the council operates under the Department of Medical Education to catalyze growth, innovation, and investment in the pharmaceutical, biotech, med-tech, and life sciences sectors. The council plays a crucial role in nurturing entrepreneurship, strengthening the pharma supply chain, and promoting R&D collaboration across public and private stakeholders.
Program Overview
This Intensive 2‑day training program provides a practical and in‑depth understanding of ISO 14155:2020 and its application in planning, conducting, and overseeing clinical investigations for medical devices. The course blends regulatory expectations, ethics, and real‑world case discussions to equip participants to design and manage compliant, high‑quality clinical investigations.
Who Should Attend ?
- Medical device R&D, clinical, regulatory, quality and safety professionals
- Pharmaceutical industry professionals involved in combination products or device‑drug studies
- Academicians and investigators conducting device or interventional research
- Postgraduate students in life sciences, pharmacy, medicine, biomedical engineering, and public health
By the end of the program, participants will be able to
- Interpret the structure and key requirements of ISO 14155:2020 and relate them to ICH‑GCP and ethical principles.
- Apply the Declaration of Helsinki, informed consent requirements, and stakeholder responsibilities in device clinical investigations.
- Develop and review Clinical Investigation Plans, Investigator’s Brochures, and essential documentation.
- Understand safety reporting, risk management linkages (ISO 14971), and expectations of regulators and ethics committees in India and globally.
- Align device studies with associated standards and guidance (e.g., CDISC‑MD, US FDA guidance, MDCG documents, India MDR).
Program Highlights (2‑Day Structure)
Day 1 – 19 January 2026
- Opening Session
- Introduction to the Declaration of Helsinki
- ICH‑GCP vs. ISO 14155
- Structure and compilation of ISO 14155
- Critical clauses, annexures, Investigator’s Brochure and study design considerations
- Clinical Investigation Plan: essential elements and practical tips
Day 2 – 20 January 2026
- Essential clinical investigation documentation
- Ethical considerations and informed consent
- Stakeholder responsibilities – sponsors, regulators, investigators, institutions, ethics committees
- Supporting and associated standards and documents (CDISC‑MD, ISO 14971, US FDA guidance, MDCG guidelines, India MDR)
- Assessment and certification
Faculty
Sessions will be delivered by experienced faculty including:
- Clinical research experts with hands-on device and pharma study experience
- Academic investigators with ethics and informed consent expertise
- Regulatory and quality professionals familiar with global and India-specific requirements
Dr. Ashish Indani - Lead Trainer
Focused on medical devices and clinical research with strong emphasis on ethics, regulations, patient perspective, and diversity. Expertise spans strategy, innovation, clinical operations, AI/ML, data science, project management, and medical writing. Well-versed in global regulatory and quality standards including US FDA, EU MDR 2017, IMDRF, ICH, GCP, and ISO 13485/14971/14155.
Sushmita Roy Chowdhury
Experienced regulatory and leadership professional specializing in strategy, client and project management within the life sciences sector. Expert in global regulatory affairs (EU, USA, ROW), regulatory intelligence, UDI, and policy advocacy, with strong engagement with health authorities and industry bodies. Proven capability in leading RIM software projects, team management, audits, risk assessments, SOP development, and vendor selection.
Priyadarshini Arambam
Accomplished Clinical Research Specialist with over 19 years of experience in designing and conducting high-quality clinical trials to advance medical science and improve patient outcomes. Board-certified SIDCER International Surveyor with certifications in GCP and Research Ethics. Experienced in multidisciplinary collaboration and building strategic partnerships across industry and academia, with a strong focus on translating research into real-world clinical practice.
Vareena Raina
Lead Auditor and Trainer with 22+ years of experience in medical device auditing, training, and system/product certification across India and the EU. Extensive expertise in Technical Documentation, including CERs and Risk Management reports, with 500+ audit man-days under ISO standards and Indian MDR 2017. Delivered 3,000+ hours of training and led successful MDR transition programs while mentoring organizations toward regulatory compliance and certification success.
Sundeep Aggarwal
Prominent leader in the MedTech sector, a visionary speaker, and a mentor to startups and innovators within the MedTech and diagnostics fields. With over 15 years of transformative experience, he expertly connects product innovation, quality, compliance, and regulatory affairs, bringing life-saving technologies closer to patients around the globe. Currently, he serves as the Senior Vice President of Regulatory & Quality (RA/QA) at Remidio. Previously, he held leadership positions, including General Manager at Datt Mediproducts.
Format and Methodology
- Interactive lectures and discussions
- Case studies and practical examples
- Q&A sessions with faculty
- End-of-course assessment and certificate
Program Details
- Dates: 19 – 20 January 2026
- Time: 10:00 – 17:30 hrs
- Venue: Hotel Clarks Avadh, Lucknow, UP
- Fees: ₹5,000 + 18% GST
- Seats: Limited seats for personalized attention
- Certification: Certificate awarded on successful completion of assessment. Joint certification by UP Promote Pharma Council, Cliniminds & Life Sciences Sector Skill Development Council.
- Additional ISO 14155 Credits would be provided by the Training team.
For queries, Contact us - 📞 +91 85959 01160, +91 95601 02589 ✉️ info@cliniminds.com
