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Drug Safety Symposium 2024 – India Chapter
Revolutionizing Pharmacovigilance Practices in India
The Drug Safety Symposium 2024 – India Chapter, held over two action-packed days, brought together industry leaders, experts, and professionals to explore innovative strategies and collaborative efforts in pharmacovigilance. With insightful, interactive, and robust sessions, the event highlighted the future of drug safety in India, emphasizing the importance of regulatory compliance, data integr... moreDrug Safety Symposium 2024 – India Chapter
Revolutionizing Pharmacovigilance Practices in India
The Drug Safety Symposium 2024 – India Chapter, held over two action-packed days, brought together industry leaders, experts, and professionals to explore innovative strategies and collaborative efforts in pharmacovigilance. With insightful, interactive, and robust sessions, the event highlighted the future of drug safety in India, emphasizing the importance of regulatory compliance, data integrity, and cutting-edge technologies like AI in enhancing pharmacovigilance systems.
The symposium kicked off with a lively Welcome Reception with an engaging ice-breaker session that helped participants transition from colleagues to friends, sharing their expectations and excitement for the event.
During the Welcome Address, Guneet Kaur Hayer, Managing Director of Eminence Group, officially opening the symposium highlighted her idea of drug safety and the vision behind hosting the India Chapter.
Day 1 Highlights:
Dr. Ranjana Pathak, President & CQO, Lupin, presented an insightful overview of enhancing Pharmacovigilance (PV) systems in India. She highlighted strategic initiatives and outsourcing practices that have fortified India's position as a global destination for pharmacovigilance.
Dr. Prasad Deshmukh, Vice President - Head PV, Cipla, provided a global perspective on PV practices, focusing on best practices from the European Union (EMA), Russia, Africa, Health Canada, and other regions. He addressed the challenges of harmonizing PV regulations globally.
Dr. Neha Vala, Head - PV, Emcure Pharmaceuticals, explored the complexities of managing the Pharmacovigilance System Master File (PSMF). Her presentation offered practical insights into ensuring regulatory compliance readiness.
Dr. Rahul Somani, Head - Global PV, Alkem, discussed optimizing vendor management strategies for PV success. He emphasized the importance of selecting the right partners, ensuring compliance, and fostering collaboration.
Before his session where he presented a detailed analysis of adverse event reporting, comparing data from India to global trends and outlining a structure for post-market surveillance in India, Dr. Somnath Basu, Scientist F, AMTZ & National Regulatory Authority (NRA), led an interactive group activity. Attendees explored the evolving landscape of pharmacovigilance regulations and identified the key stakeholders responsible for ensuring drug safety.
Dr. Abhay Chimankar, Founder, of Rhyme Life Sciences presented Risk Management Plans (RMPs), focusing on their development, submission, and integration into overall safety strategies. Following this, Ms. Bhageswari Sreeraman, VP - Products, 3Analytics, discussed the transformative impact of AI in signal detection. She highlighted real-world instances where AI innovations led to significant outcomes.
The panel discussion on Optimizing Existing Infrastructure was moderated by Ms. Guneet Kaur Hayer. The panel featured Dr. Devang Patel, Head – of Global Pharmacovigilance, Zydus Life Sciences, Dr. Mukesh Gori, Associate Director-ESP Management PV Operations, and Dr. Rahul Somani. The discussion centered on enhancing drug safety practices using existing resources, with insights into innovative strategies and practical approaches.
Day 2 Highlights:
Day 2 began with a recap of Day 1 highlights and an engaging pop quiz to refresh attendees' memories and set the stage for the day's sessions.
Geeta Shanbhag, Vice President – PV and Medico-regulatory Affairs, IPCA Laboratories, presented on data integrity and governance in PV. She explored topics such as data security, documentation, and the role of AI.
Dr. Rajendra Kumar Kasi, Vice President & Global Head – PV, Glenmark Pharmaceuticals, discussed best practices for PV audits. He provided practical insights to help organizations achieve audit success and maintain compliance.
Dr. Rashmi Hegde, Executive Vice President – Medical, GSK Pharmaceuticals, shared strategies for strengthening compliance and enhancing patient safety. Her presentation included real-world case studies and effective mitigation techniques.
Dr. Aswin Kumar, Global Medical Writing Head, Viatris, led sessions on the intersection of drug safety, medical writing, and regulatory compliance.
Group Activity: Safety Communications Interactive discussions allowed participants to share experiences, insights, and best practices related to safety communication. They developed action plans for implementing effective communication strategies within their organizations.
Rejuvenating Activity Attendees took a moment to recharge with an energizing activity designed to refresh their minds and bodies, preparing them for the final sessions of the symposium.
Panel Discussion: Elevating Safety Communications Moderated by Dr. Aswin Kumar, the panel included Dr. Devang Patel, Dr. Jamal Baig from Sanofi and Dr. Chetanraj Bhamare from Serum Institute if India. The discussion focused on integrating drug safety and pharmacovigilance strategies to enhance safety communications, covering topics such as risk minimization, vaccine safety communication, and handling safety communications in Indian companies.
The event concluded with a dedicated Q&A session, allowing attendees to clarify doubts and summarize key takeaways from the two-day symposium.
Conclusion The Drug Safety Symposium 2024 – India Chapter was a tremendous success, offering valuable insights into the evolving landscape of drug safety. The event facilitated knowledge sharing, networking, and collaboration among industry leaders, ensuring that attendees left with a deeper understanding of innovative strategies, practical approaches, and collaborative efforts essential for advancing pharmacovigilance practices.
Industry Leaders Converge for 4th Computer Software Assurance 2024:
Enhancing Pharma Compliance and Innovation
The 4th Computer Software Assurance 2024: CSx - Define your Variable and Assure your Validation, held by Eminence Business Media on June 20th-21st, 2024 at Radisson Blu Mumbai International Airport, was a resounding success. The event featured over 100 delegates, and industry leaders offering tailored solutions to streamline the CSV process for pharma companies. With dedicated Q&A ro... moreIndustry Leaders Converge for 4th Computer Software Assurance 2024:
Enhancing Pharma Compliance and Innovation
The 4th Computer Software Assurance 2024: CSx - Define your Variable and Assure your Validation, held by Eminence Business Media on June 20th-21st, 2024 at Radisson Blu Mumbai International Airport, was a resounding success. The event featured over 100 delegates, and industry leaders offering tailored solutions to streamline the CSV process for pharma companies. With dedicated Q&A rounds, presentations, and case study discussions throughout the day, the event proved to be both informative and interactive.
Inaugural Day Highlights
The event commenced with a ceremonial lamp lighting by notable figures such as Mr. Ken Shitamoto, Executive Director IT Quality and Compliance at Gilead Life Sciences, Mr. Biju George, Head IT GMP Operations & CSV at Alembic Pharma, Mr. Yogesh C. Jagtap, Principal e-Compliance Specialist at Dr. Reddy’s Laboratories, and Ms. Guneet Kaur Hayer, Managing Director of Eminence Group.
Ms. Guneet Kaur Hayer delivered an inspiring welcome note, underscoring the importance and challenges of Computer Software Validation/Assurance. Her address set an enthusiastic tone for the event.
Day 1: Current Trends, Challenges, and Regulatory Frameworks
• Workshop by Mr. Ken Shitamoto: Mr. Shitamoto led a group activity on advanced testing techniques, comparing pre-defined scripts with ad-hoc testing, and discussing the application of CSA/SV principles using agile thinking.
• Industry Presentations:
o Nandhini Natarajan: Shared insights on CSA transformation using AI in pharma testing, focusing on efficiency, accuracy, and compliance.
o Yogesh C. Jagtap: Discussed regulatory frameworks and strategies for staying compliant, including regulations triggering CSA/CSV like 21CFR 211.68 & EU Volume 4/Ch 3.
o Sarada Ramamoorthy: Explored the step-by-step implementation of GAMP principles in software development and validation.
o Ragavan Sundararajan & Rangarajan Rajamani: Highlighted the top forces driving CSA transformation, emphasizing a shift from processes to behaviours and fostering critical thinking.
• Panel Discussion: Moderated by Mr. Ken Shitamoto, the session featured insights from experts on future readiness in CSV/SA, including Mr. Munish Kumar Sharma and Mr. Biju George.
Day 2: Data Governance, Security, and Integrity
• Roadmap to Successful CSA Implementation: Deepa Pangaonkar focused on creating a CSV quality culture and CSA mindset, sharing a live case study.
• Rishabh Tripathi: Addressed maintaining data integrity and compliance through robust data governance frameworks and the risks associated with data breaches.
• Yogesh C. Jagtap: Covered agile and SCRUM technology, illustrating successful agile methodology implementation with a case study from Dr. Reddy’s.
World Yoga Day: Balanced Mind & Body, Successful Validations
Gayatri Singh, a renowned Yoga and Mindfulness Instructor, led a session to relax attendees' minds and bodies, highlighting the benefits of a calm mind for enhanced productivity.
Case Study Session
Deepa Pangaonkar and Nitesh Gaonkar led a brainstorming session, solving case studies on online SCA implementation on production equipment and validating document management systems applying CSA.
Acknowledgments: Celebrating Partnerships and Collaborations
The event's success was supported by esteemed partners such as Archimedis, Sikich, and media partners, whose contributions were invaluable in advancing quality standards in the pharma industry.
Conclusion: Inspiring Change and Driving Collaborations
As the 4th Computer Software Assurance 2024 concluded, participants left feeling rejuvenated and motivated. The event provided valuable insights, collaborations, and practical knowledge, paving the way for positive change and transformation in the pharmaceutical landscape.
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