pvindia Autumn forum success: Unlocking Pharmacovigilance Insights for a Safer World

In the ever-evolving landscape of Pharmacovigilance (PV), a parallel momentum is gaining traction — the imperative for transparency and heightened responsibility towards ensuring patient safety. Organizations operating in PV are now facing heightened pressure to demonstrate tangible progress. Transparency is the need of the hour. As we stand at this critical juncture, pvindia 2023 provided a neutral transparent platform that explored the pivotal steps needed to unlock opportunities on the path to a more sustainable, equitable, and inclusive PV industry. On October 5^th 2023, pvindia hosted its 15^th forum, where leading PV experts came together to discuss what's required for progress.

The Immense Potential of pvindia: A closer look at the Insights shared.

The 15^th pvindia forum sessions included value sharing by experts such as Dr Mangala Kotnis, a healthcare specialist with 18+ years of experience in pharmaceutical industry, Dr Jamal Baig, Multi Country Safety Head at Sanofi, Dr Anuja Jawale (Sawant), Associate Director - RA/PV Strategic Engagements and Vendor Management at Organon, Dr Manoj Swaminathan, Director - Safety and Pharmacovigilance at Biorasi, Dr R. Arun Kumar, Associate Scientific Director, Safety Evaluation & Risk Management at GSK, and Kunal Banshinge, Product Manager Springer Nature Technology And Publishing Solutions.

The forum was facilitated by Dr. Latika Sharma, PV Networks Lead & Senior Management Consultant at Navitas Life Sciences and technology insights provided by Mohanraj P, Senior Manager, Product Development, Navitas Life Sciences.

pvindia shows the way towards the future of PV: Driving value, Driving Success

pvindia has the potential to revolutionize the entire pharmacovigilance function, improving patient experience and drug safety through insights on digital tools and enhancing and augmenting expert skills.

However, what will drive value over the next few years? As companies rush to adapt and implement strategies for enhanced pharmacovigilance, understanding pharmacovigilance’s potential to deliver value to the patient and society at large will help shape critical decisions. The forum aided in using complementary lenses from experts across the Indian pharmaceutical landscape to determine where pharmacovigilance, with its current capabilities, could deliver the biggest value and where it is heading towards.

Hot Topics from pvindia 15^th Forum

• Automation AI based validated software demo
• Innovation and new technologies in PV (PSFM, Reg intel, HA perspectives, workforce changes)
• Best practice in Literature, AR and signal management
• Regulatory intelligence screening and implementation
• Medical device and combination product safety

In this blog, we interviewed Dr. Latika Sharma and Elsa Reus, Nets PV Project Manager, Consulting & Nets, Navitas Life Sciences to understand more about the 15th pvindia forum and the insights that were shared.

Dr Latika Sharma

PV Networks Lead Consulting & Nets

Navitas Life Sciences

Please tell us more about your professional journey:

I am a trained post graduate physician with over 20 years of experience spanning medical practice, military services, academia and industry. At medical school, the 3 Ps (physiology, pathology, and pharmacology) always fascinated me; how does the body function in normal state? What goes wrong during disease state? How do medicines work? While practicing medicine in a range of healthcare settings (armed forces/civil, primary through tertiary) greatly honed my clinical and patient skills. I was attracted to the concept of clinical research/epidemiology and its potential to positively impact ‘populations’ rather than individual patients, one at a time. My interest in pharmacology, public health and research made PV a great choice for me. I started my PV career as a manager leading a Medical review team, followed by building/heading up a full-fledged PV practice and am currently leading PV networks at Navitas Lifesciences

Kindly give us a retrospective overview of pvindia's 15^th forum

The 15^th edition of pvindia was hosted by Navitas Life Sciences as an in-person event on the 5^th of October 2023 at ITC Maratha Mumbai. As the forum was by invitation only, we had a select group of ~45+ senior PV participants representing 29 companies (MNC and India HQ) from the bio-pharma industry.

The seven case studies and thought-provoking discussions highlighting potential of cutting-edge technology in PV, challenges imposed by regulatory disharmony including risk management and future of audits and inspections, effectively summed up the theme “Emerging PV Landscape- What now, Where next?”

Regulatory intelligence monitoring and implementation, global-local alignment and sustaining highest quality and compliance in the wake of an ever-evolving regulatory landscape and increasing financial pressures are the top strategic priorities for pvindia.

We kick-started the day with reflections from Dr Mangala Kotnis, a healthcare specialist with 18+ years of experience in pharmaceutical industry, highlighted the myriad possibilities of leveraging Artificial intelligence on PV. She also explored the implications of scientific advancements like ATMPs and digital therapeutics on patient safety. Along with the anticipation of novel technologies comes the responsibility of data privacy, security, transparency, and ethics.

This was followed by a very comprehensive overview of RMP & aRMMs from Dr Jamal Baig, Multi Country Safety Head at Sanofi, leading to a very thought-provoking discussion on interpreting RMP submission requirements and implementing them in India.

Dr Anuja Jawale (Sawant), Associate Director - RA/PV Strategic Engagements and Vendor Management at Organon, exemplified how disharmony of global regulations adds to the complexity in an already over-burdened PV system. She also highlighted the pressing need for intensification of industry-HA collaboration to simplify requirements focusing on meaningful outcomes.

Dr Manoj Swaminathan, Director - Safety and Pharmacovigilance at Biorasi, gave us insights into the future of remote audits and inspections- ‘metaverse with virtual reality’, and accompanying challenges/solutions around technology, acceptability, and trust!

The tech showcase was a veritable mix of home-grown innovation and external PV solutions:

• Clinical utilization score for prioritization (CUSP) from Dr R. Arun Kumar, Associate Scientific Director, Safety Evaluation & Risk Management at GSK
• safetyREADY platform solution for signal management from Mohanraj P, Senior Manager • Product Development, Navitas Life Sciences and
• AI enabled literature surveillance tool from Kunal Banshinge, Product Manager Springer Nature Technology And Publishing Solutions.

How has PV India demonstrated growth and progress since its inception in March 2016, and what were the standout moments from the recent forum?

We celebrated the 15th edition of pvindia this time and the pvindia community is growing from strength to strength. Over the years, there has been growing recognition of patient safety as an important public health topic among industry, regulators and HCPs in India, heightened awareness, and expectations among patients-fueled by the COVID-19 experience and more global-local collaboration.

How does one implement aRMMs for carbamazepine in the Indian primary healthcare context?

India with over 1.3 Bn population is at the cusp of development and transformation. Being one of the biggest markets for innovator drugs and generic exports has strategic, business, and public-health implications. The Indian genetic makeup, cultural beliefs & customs, socio-economic indicators, and healthcare set up must be considered whilst strategizing drug development, commercialization and risk management measures-making it truly ‘’ fit for purpose.’’

In your opinion, what were the most significant takeaways from providing a neutral platform for pharmacovigilance leaders to connect and collaborate?

pvindia is unique as it draws upon the most recent themes and strategic discussions from our flagship networks pvnet (top 30) and pvconnect (SMB). These insights enable Indian PV stakeholders to contextualize and build their patient safety strategy globally and locally.

In line with our global network code-of conduct, we offer these on a platform as a means to ideate, network and collaborate through neutral facilitation, audience engagement and sans the pressures of sponsorship/sales.

Looking ahead, what are the anticipated developments or initiatives on the horizon for PV India, and how might they shape the future of pharmacovigilance in the APAC region?

We will continue to shape the pvindia agenda through forum hot topics and invite industry thought leaders for future sessions.

We are open to hearing from our pvindia community on their aspirations and support them on their endeavors.

Elsa Reus

pv Nets Project Manager
Consulting & Nets,

Navitas Life Sciences

Please share insights into the prevalent challenges discussed during the forum, and how participants explored strategies to address them.

During the pvindia forum, members discussed what were the biggest challenges in the PV space right now. Most important challenges were keeping up with regs, audits and inspections; maintaining quality and compliance; technology and transformation projects, and lastly, resource constrains (budget, skills).

Were there specific themes or subjects that received special attention during the Autumn forum? How did these topics resonate with participants?

We discussed a diverse number of themes during the forum. From future of PV, PV technology, risk minimization, to audits & inspections & evolving PV regulatory landscape. All the topics received great interest and resonated with the participants of pvindia.

What would you like to tell prospective members?

Joining pvindia is a unique opportunity to be part of an industry leading global network for Pharmacovigilance professionals. We look forward to welcoming you to the next forum!

pvindia 2023 presented a unique platform for industry leaders, experts, and stakeholders to converge and address the critical discussions on Pharmacovigilance and drug safety. Through insightful discussions and shared expertise, the conference aimed to chart a course towards enhanced patient safety. The insights gained during this forum will undoubtedly have far reaching effects, in terms of influencing the future trajectory of PV practices globally.

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