XXth Annual Conference of Society of Pharmacovigilance (India): SOPICON 2023

INTRODUCTION The Society of Pharmacovigilance India (SoPI) is a national non-profit scientific organisation, which aims to foster Pharmacovigilance activities among healthcare professionals. SOPICON is an annual conference being conducted by the society from 2002 to enhance all the aspects of the safety issues of medicines. The 20th Annual Conference of SOPICON was organised during 10–12 May 2023 by All India Institute of Medical Sciences, Rishikesh in collaboration with SOPI. The theme of SOPICON-2023 was ‘Medication Safety in an Era of Evidence-Based Medicine’. UNIQUE ASPECTS OF SOPICON-2023 CONFERENCE This conference was organised with the intent to provide a suitable platform for discussion about different issues pertaining to the safety of medicinal products ranging from the quality of pharmaceuticals to the pooled analysis of safety data from the clinical investigations. A collaborative discussion among healthcare professionals from the diverse fields on a shared platform provided delegates with valuable insights into various aspects of medication errors, particularly in patient care and medication safety. PRE-CONFERENCE WORKSHOPS The program was initiated with a pre-conference workshop on 10th May 2023 to provide hands-on experience to 50 delegates about software used for uploading and analysing information pertaining to drug safety [Figure 1]. The programme aimed to enhance delegates’ skills by familiarising them with two key software applications for collecting adverse drug reaction data: Vigiflow and Oracle Argus. In addition, delegates were introduced to the management practices of Materiovigilance and the Signal Review Process at the Indian Pharmacopeia Commission. This comprehensive approach aimed to strengthen the delegates’ overall understanding of pharmacovigilance and patient safety systems in India, equipping them with both the technical and managerial skills required for effective medication safety management.Figure 1: Pre-conference workshopSOPICON-2023 CONFERENCE The program was initiated with an inaugural ceremony on 11th May 2023 by our Chief Guest, Prof. Meenu Singh, CEO and Director, AIIMS, Rishikesh, emphasised the importance of Pharmacovigilance and active reporting of adverse drug reactions in the current era of evidence-based medicine. The programme was introduced by Prof. Shailendra Handu, Organizing Chairperson of SOPICON 2023, Professor and Head of Department of Pharmacology, AIIMS Rishikesh. Following this, Dr. Sandeep Agarwal, President of SOPI India, emphasised the critical role of adverse drug reaction reporting in evidence-based medicine. The first session of conference was the prestigious John Autian Oration, which was delivered by Prof. Balaram Bhargava on the topic ‘India’s COVID Vaccine Saga and Role of Indian Council of Medical Research (ICMR)’. The speaker enlightened the audience about the process of detection, management and vaccine preparation of COVID-19. He highlighted the numerous challenges faced by ICMR and how they were overcome through sheer grit and determination. The oration also shed light on the logistical difficulties encountered, particularly in delivering vaccines to the remote areas such as Northeast India. He shared how innovative solutions, such as the use of drones, were employed to ensure vaccine delivery in these hard-to-reach regions [Figure 2].Figure 2: Prof. Shailendra Handu, Prof. K. C. Singhal, Prof. Balram Bhargava, Prof. Meenu Singh, Prof. Jaya Chaturvedi, Prof. Syed Ziaur Rehman, Dr. Puneet Dhamija (From left to right)The second session, themed ‘Pharmacovigilance: An Overview’, provided valuable insights into the field of pharmacovigilance. Dr. Manisha Bisht introduced the topic ‘Pharmacovigilance: Global and Indian Scenario’, while Dr. Renu Gulwani discussed ‘WHO Pharmacovigilance Indicators’. This session was designed to help the audience understand and orient themselves to key pharmacovigilance concepts, setting a solid foundation for the more advanced topics covered in the subsequent sessions of the program. The third session, themed ‘Medication Errors and Drug Safety’, focused on the critical aspects of ensuring patient safety. The session covered the reporting of medication errors, clinical pharmacological reconciliation and the importance of review and feedback in preventing and managing these errors. The goal was to enhance understanding and practices related to medication safety and error management. The next session, themed ‘Drug Use in Special Populations’, included discussions on ‘Drug-induced Liver Injury’ and ‘Pharmacovigilance for Patient Safety’. This session aimed to address the unique considerations and challenges in managing drug use among special populations, as well as the importance of pharmacovigilance in ensuring patient safety. The fifth session, themed ‘Artificial Intelligence in Drug Use’ focused about the role of AI and machine learning technologies in drug safety assessments and their broader impact on healthcare practices, highlighting how these technologies can enhance drug safety and overall patient care. The next day of the conference began with the sixth session, themed ‘Drug and Device Safety Issues’. This session covered important topics such as ‘Materiovigilance for Patient Safety’ and ‘Post-Marketing Safety Surveillance of Drug-device Combination Products’, focusing on ensuring safety and monitoring of both drugs and medical devices throughout their lifecycle. The seventh session featured K. C. Singhal Oration which was delivered by Padma Shri Prof. Daya Kishore Hazra on the topic ‘Pharmacovigilance in relation to Diabetes Interventions’. Prof. Hazra emphasised the critical role of pharmacovigilance to ensure the safety of diabetes medications and extending the indications for existing drugs. He highlighted the importance of spontaneous reports, passive surveillance and case reports in identifying and managing adverse events. The eighth session, themed ‘Pharmacovigilance for AYUSH’, focused on the safety of traditional medicines. It addressed the importance of pharmacovigilance in monitoring and ensuring the safety of AYUSH (Ayurveda, Yoga, Unani, Siddha and Homeopathy) therapies, highlighting the need for robust safety practices and reporting systems in traditional medicine. The theme of ninth session was Environmental Pharmacology that includes discussion about Carbovigilance. The speaker highlighted the importance of reducing the carbon footprints of pharmaceutical industries and their adverse environmental impact. He explained the methodologies and conduct of studies related to carbovigilance and stressed the need for increased attention to these studies to protect the environment. The tenth session, themed ‘Vaccine Safety’. The discussion focused on the safety measures, monitoring and findings related to COVID-19 vaccines during their clinical development phases. This session also included a discussion on topic ‘Health Economics and Safety Outcomes Research’ that briefed about health-economic evaluations and explanation of how safety plays a role in cost-effectiveness of a drug. The speaker emphasised that many cost-effectiveness studies tend to overlook safety aspects, potentially undermining the overall patient outcomes and the true cost of drug-related adverse effects. At the end of the conference, the SOPICON-2023 successfully brought together experts, practitioners and industry leaders for a panel discussion that emphasised the potential benefits of prescribing generic medicines, provided there is a strong assurance of quality for these drugs. The panel underscored the need for ensuring quality standards and raising awareness among prescribers and consumers to promote the safe and effective use of generic medications. NEED OF FUTURE CONFERENCES LIKE SOPICON-2023 This conference was organised to enhance the skills and in-depth knowledge of delegates for understanding all the aspects of pharmacovigilance activities. Preconference workshop enhanced the skills needed to effectively utilise pharmacovigilance tools, manage medication safety and conduct safety assessments. The conference provided a common platform for delegates to connect with industry experts, peers and stakeholders, fostering professional relationships and collaborative opportunities. Sessions on emerging topics, such as the use of AI in drug safety and challenges in special populations, help delegates stay informed about current and future challenges in the field. The knowledge and experiences shared during the conference can motivate delegates to advocate for and implement improvements in pharmacovigilance practices within their own organisations and provide a safer treatment environment for patients. Financial support and sponsorship Nil. Conflicts of interest There are no conflicts of interest.