13th Annual Clinical Trials Summit 2022

13th Annual Clinical Trials Summit 2022

WHY SHOULD YOU ATTEND?

Get more from the event, with a broader scope bringing the whole communications value chain together. Enjoy and make the best out of our dedicated networking time, meet the leading international vendors showcasing the products of tomorrow in the co-located exhibition. Expand your knowledge of the latest business models and strategies in the high-level conference.

Event Speakers

SADHNA J

Sun Pharma

PRATIK SHAH

Bharat Serums and Vaccines

RAGHURAM J

Tenthpin

KIRAN MARTHAK

Veeda Clinical Research

MILIND ANTANI

Nishith Desai Associates

DEEPA ARORA

CLINEXEL Life Sciences

RAKESH PATEL

Veeda Clinical Research

DILIP PAWAR

Unichem Laboratories

MUKESH GORI

Novartis

KRISHNA C V

Dr. Reddy's Laboratories

SADANAND K

Fresenius Kabi

GOPAL NANDAN

Oncquest Laboratories

INDRANIL P

Ipca Laboratories

ASHWANI P

Glenmark

VISHWAS SOVANI

Pharmawisdom

ROSHAN PAWAR

Alkem Laboratories

SAKHARAM G

Renovare Healthcare

“A critical guide for successfully conducting clinical trials”

Event Schedule

Meet and to network with your conference colleagues.

08:30 – Coffee and registration – An opportunity to meet and to network with your conference colleagues.

09:20 – Chairperson opening remarks
PRATIK SHAH, Vice President Medical Affairs, Bharat Serums and Vaccines

CHALLENGES & OPPORTUNITIES

09:30 – Getting Future Ready – Standards Driven Automations – Possibility & Opportunities

  • CRF concepts and submission concepts
  • Third part data and data cleaning
  • How standards (global + company) can drive automations?
  • SDTM/ADaM concepts and TFL concepts

TUSHAR SAKPAL, Director - Clinical Data Standards & Automation, Novartis

10:00 – DISCUSSION WITH EXPERTS: Key changes and visible trends in clinical trials

  • Challenges and lessons learned from Covid-19 trials
  • What can we anticipate for clinical development post pandemic? Barriers in adoption of new normal
  • Opportunities and challenges of collecting wearable data in decentralized trials
  • The growth of hybrid trial & virtual trials in India.
  • Prioritizing study risks and learning from past experiences
  • Digital transformation and AI in clinical trials
  • Planning for better clinical trials globally.
  • Clinical trials in Nutraceuticals: The new frontier?

Moderator:
DILIP PAWAR, Head - Medical Affairs and Pharmacovigilance, Unichem Laboratories


Panellist:
SANDESH SAWANT, Senior Director, Medical Services Head - Clinical Trials, Cipla
RAKESH PATEL, Associate Vice President – Clinical Operations (Head – Projects), Veeda Clinical Research

ANIKET JOSHI, Associate Global Portfolio Delivery Director, Novartis
CHIRAG TRIVEDI, Clinical Study Unit Cluster Head, Sanofi
KEDAR NAYAK, Head - Clinical Development, GSK
KRISHNA C VELIGANDLA, Lead, Medical Affairs, Dr. Reddy's Laboratories
ARUN BHATT, Consultant – Clinical Research & Development

11:00 – Morning Coffee/Tea & Discussion

PATIENT SAFETY

11:20 – DISCUSSION WITH EXPERTS: Ensuring the patient safety and centricity in clinical trials.

  • What are key challenges in patient safety? Ways to overcome and better alternatives.
  • Enhancing patient-site centricity and clinical innovation through technology
  • What can we do better to improve patient recruitment?
  • Impact of technology in field of clinical trials  - where are we heading with these developments and what’s next?
  • Role of DCT methods in the process of patient enrolment and safety.
  • How much data is used and what information is shared with the patient?
  • Risk-based monitoring (RBM) – Is ensuring patient safety?

Moderator:
RAGHURAM JANAPAREDDY, Partner & Managing Director – India, Tenthpin


Panellist:

MUKESH KUMAR, Senior Vice President  & Head, Clinical R&D, Cipla
KIRAN MARTHAK, Non - Executive Director, Veeda Clinical Research
MUKESH GORI, Associate Director - ESP Management PV Operations, Novartis
MANGALA KOTNIS, Head Regional Medical Affairs, Abbott
INDRANIL PURKAIT, Sr. General Manager and Head Medical Affairs, Ipca Laboratories

ROSHAN PAWAR, Associate General Manager, Alkem Laboratories

12:20 – Oncology Clinical Development - Efficient Early Phase Execution

  • Focus on robust science and geographies levers to optimize cost, timelines and robust decisions

DEEPA ARORA, Founder - Director, CLINEXEL Life Sciences

 

12:40 –Networking luncheon

CRO RESPONABILITIES

13:50 – DISCUSSION WITH EXPERTS: Risk identification and quality management in sponsorship

  • What are the key market trends and challenges driving opportunities and outsourcing?
  • Recognizing the challenges of navigating multiple stakeholders.
  • Focusing on the relationship between CROs and sponsors – What are the distractions?
  • Discussing the current industrial trends globally and in India as well.
  • End-to-end strategic partnership and managing the communications gap
  • Ensuring that high quality data is collected as part of CRO collaboration
  • How can sponsors successfully manage the EU CTR change?

Moderator:
VISHWAS SOVANI, Founder Director, Pharmawisdom

Panellist:
PRATIK SHAH, Vice President Medical Affairs, Bharat Serums and Vaccines

DIVAKAR KOLLI, Associate Director and Head - Clinical & Non-Clinical QA, Cipla
VAIBHAV SALVI, Head – Medical Information, Asia, Sanofi
ASHWANI PANDITA, General Manager Quality Management & Training, Global Clinical Research Operations, Glenmark

SAKHARAM GARALE, Founder & CEO, Renovare Healthcare Solutions

14:40 – Central Lab: Oncquest Laboratories Ltd: Capability Presentation & Role of Central Lab in Clinical Trials

GOPAL NANDAN, Sr. Manager: Clinical Trials, Oncquest Laboratories

15:00 – Afternoon Tea/Coffee

15:20 – Early phase development: Is India ready?

SADHNA JOGLEKAR, Head, Global Drug Development India, Novartis


REGULATORY

15:50 – DISCUSSION WITH EXPERTS:  Recent changes in regulatory aspect of clinical trials in India

  • Ensuring and maintaining compliance with the rules and regulations.
  • Following the pandemic, what are the regulatory challenges for the CRO industry?
  • Delays in approval from regulatory agencies. What needs to be done?
  • Protecting safety: Standardizing and streamlining the regulatory process

Moderator:
MILIND ANTANI, Leader, Pharma and Healthcare, Nishith Desai Associates


Panellist:
YASMIN SHENOY, Director-Regulatory Affairs, Sanofi
RAHUL GUPTA, Sr. Vice President – Regulatory Affairs, USV
HARSHAD KOTHAWADE, Head-Regulatory Management & Trade Compliance, Merck
SADANAND KULKARNI, Head-Medical, Regulatory, Vigilance, Quality, Fresenius Kabi

16:40 - Chairperson’s closing remarks and end of conference
PRATIK SHAH, Vice President Medical Affairs, Bharat Serums and Vaccines

Event Sponsors & Partners

We wouldn’t be able to host our conferences without help from these amazing companies. A huge thanks to all our sponsors and partners!

Virtue Insight

CONCEPTUALISED BY

Clocate

SUPPORTED BY

Townscript

SUPPORTED BY

Testimonials

A huge thanks to all our sponsors, attendees and partners!

Testimonials

A huge thanks to all our sponsors, attendees and partners!

Get Involved

Sponsor / Exhibit / Delegate Bookings
Speaking Opportunities

Attendee List

No attendee found
  • Date : 19 May 2022
  • Time : 9:30 am - 6:00 pm (Asia/Kolkata)

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