Page 153 - CW E-Magazine (9-7-2024)

Pharmaceuticals Pharmaceuticals

DRUG SAFETY SYMPOSIUM 2024 – INDIA CHAPTER integrity and governance in PV. She Writing Head, Viatris, led sessions on Panel Discussion: Elevating Safety
Revolutionising pharmacovigilance practices in India explored topics such as data security, the intersection of drug safety, medical Communications
Moderated by Dr. Aswin Kumar,
documentation, and the role of AI.
writing, and regulatory compliance.
the panel included Dr. Devang
The Drug Safety Symposium Dr. Rajendra Kumar Kasi, Vice Group Activity: Safety Communications Patel, Dr. Jamal Baig from Sanofi
2024 – India Chapter, held over two President & Global Head – PV, Glen- Interactive discussions allowed and Dr. Chetanraj Bhamare from
action-packed days, brought together mark Pharmaceuticals, discussed best participants to share experiences, Serum Institute of India. The dis-
industry leaders, experts, and practices for PV audits. He provided insights, and best practices related to cussion focused on integrating
professionals to explore innovative practical insights to help organizations safety communication. They developed drug safety and PV strategies to
strategies and collaborative efforts in achieve audit success and maintain action plans for implementing effective enhance safety communications,
pharmacovigilance. With insightful, compliance. Dr. Rashmi Hegde, Execu- communication strategies within their covering topics such as risk mini-
interactive, and robust sessions, the tive Vice President – Medical, GSK organizations. mization, vaccine safety com-
event highlighted the future of drug Pharmaceuticals, shared strategies for munication, and handling safety
safety in India, emphasizing the im- strengthening compliance and enhanc- Rejuvenating Activity communications in Indian com-
portance of regulatory compliance, ing patient safety. Her presentation Attendees took a moment to panies. The event concluded with a
data integrity, and cutting-edge tech- included real-world case studies and recharge with an energizing activity dedicated Q&A session, allowing
nologies like AI in enhancing pharma- effective mitigation techniques. designed to refresh their minds and attendees to clarify doubts and
covigilance systems. bodies, preparing them for the fi nal summarize key takeaways from
Dr. Aswin Kumar, Global Medical sessions of the symposium. the two-day symposium.
The symposium kicked off with a
lively Welcome Reception with an enga- INVESTMENT PLAN
ging ice-breaker session that helped explored the complexities of managing and integration into overall safety Navin Molecular pumps in Rs. 288-crore to boost
participants transition from colleagues the Pharmacovigilance System Master strategies. Following this, Ms. Bhages-
to friends, sharing their expectations File (PSMF). Her presentation offered wari Sreeraman, VP – Products, GMP manufacturing capabilities at Dewas site
and excitement for the event. During practical insights into ensuring regula- 3Analytics, discussed the transfor-
the Welcome Address, Ms. Guneet tory compliance readiness. mative impact of AI in signal detection. Navin Molecular, the pharma-fo- A ground-breaking ceremony took
Kaur Hayer, Managing Director of She highlighted real-world instances cussed contract development and manu- place at the site in April this year, and
Eminence Group, offi cially opening Dr. Rahul Somani, Head – Global where AI innovations led to signifi - facturing organisation (CDMO) divi- the project is scheduled to be complet-
the symposium highlighted her idea of PV, Alkem, discussed optimizing ven- cant outcomes. sion of Navin Fluorine, has announced ed by the end of 2025.
drug safety and the vision behind host- dor management strategies for PV suc- a Rs. 288-crore investment to construct
ing the India Chapter. cess. He emphasized the importance of The panel discussion on Optimizing a 9,000-square-metre GMP manufac- “As our business expands, we are
selecting the right partners, ensuring Existing Infrastructure was moderated turing plant in Dewas, Madhya Pradesh. progressing numerous projects to in-
Day 1 Highlights compliance, and fostering collabora- by Ms. Guneet Kaur Hayer. The panel crease in scale towards commercial
Dr. Ranjana Pathak, President & tion. Before his session, where he featured Dr. Devang Patel, Head – of The new facility will nearly double while reducing risks to employees and manufacturing, as well as investing in
CQO, Lupin, presented an insightful presented a detailed analysis of adverse Global PV, Zydus Life Sciences, overall capacity at the site to 420 the environment. new, more advanced and niche techno-
overview of enhancing Pharmaco- event reporting, comparing data from Dr. Mukesh Gori, Associate Director- cubic metres, and will support existing logies that we had previously identifi ed
vigilance (PV) systems in India. She India to global trends and outlining a ESP Management PV Operations, and commercial-scale projects, as well as Supporting the manufacturing in- as growth opportunities. Combined,
highlighted strategic initiatives and structure for post-market surveillance Dr. Rahul Somani. The discussion centered meeting future demands. Multi-purpose frastructure, the expansion will also in- this additional capacity and broadened
outsourcing practices that have fortifi ed in India, Dr. Somnath Basu, Scientist F, on enhancing drug safety practices in design, the facility will add 200 cubic crease the size and capacity of the site’s technology platform will not only
India’s position as a global destination AMTZ & National Regulatory Authority using existing resources, with insights metres of manufacturing capacity, us- existing 21 CFR-complaint quality satisfy these growing volumes, but will
for pharmacovigilance. (NRA), led an interactive group acti- into innovative strategies and practical ing different vessel types including control laboratory, to carry out in-pro- build for the future enabling us to capi-
vity. Attendees explored the evolving approaches. stainless steel, glass-lined, Hastelloy cess testing and fi nal product release. talise on both horizontal and vertical
Dr. Prasad Deshmukh, Vice Presi- landscape of pharmacovigilance regu- and Inconel. It will be capable of un- A new process safety laboratory will market openings,” said Mr. Rajendra
dent – Head PV, Cipla, provided a global lations and identifi ed the key stake- Day 2 Highlights dertaking a range of chemistries, in- be constructed, as well as a dedicated Kumar Sahu, Chief Executive Offi cer
perspective on PV practices, focusing holders responsible for ensuring drug Day 2 began with a recap of Day 1 cluding hazardous processes such as zero liquid discharge (ZLD) effl uent of Navin Molecular. Navin Molecular
on best practices from the European safety. highlights and an engaging pop quiz direct fl uorination, cyanation, azide treatment plant. Its construction will was launched in 2023, and its 47-acre
Union (EMA), Russia, Africa, Health to refresh attendees’ memories and chemistry, cryogenic reactions and comply with India’s optimum green site in Dewas offers process research
Canada, and other regions. He ad- Dr. Abhay Chimankar, Founder, set the stage for the day’s sessions. high-pressure hydrogenation. The plant building concepts, leveraging modern and development through to commer-
dressed the challenges of harmonizing Rhyme Life Sciences presented Risk Ms. Geeta Shanbhag, Vice President – will include a high level of automated technologies in materials, equipment cial manufacturing of a wide-range of
PV regulations globally. Dr. Neha Vala, Management Plans (RMPs), focusing PV and Medico-regulatory Affairs, control, including a distributed control and design, including renewable energy regulatory starting materials and API
Head – PV, Emcure Pharmaceuticals, on their development, submission, IPCA Laboratories, presented on data system (DCS), maximising effi ciency generation and solvent containment. intermediates.

152 Chemical Weekly July 9, 2024 Chemical Weekly July 9, 2024 153

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