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Scientific deliberation on adverse impact of drug reactions 

Academicians, industry experts, faculty, students pledges to create more awareness among health care professionals, patients, attendants and the common masses about impact of various drugs as well as medicines

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School of Pharmaceutical Sciences at Apeejay Stya University recently concluded National Pharmacovigilance Week on the theme ‘Encouraging Reporting of Adverse Drug Reactions by Patients’

The week-long event (held from September 17 to 23) saw participation from academicians, industry experts, faculty members and students.

Among the speakers, Mr. Kuldeep Kinja, Deputy Manager and Mr. Neeraj Kumar, Assistant Manager – Medical Affairs and Communication at APCER Life Sciences were invited as the guest speakers for a technical session. 

Sharing his thoughts on the topic “Pharmacovigilance and its phases”, Mr Kinja explained the definition and objective of Pharmacovigilance as well as the meaning of Adverse Event, Adverse Drug Reaction and Causality Assessment, as well as Product Quality Complaint (PQC). 

Subsequently, Mr. Neeraj Kumar explained about Medical Information – its meaning and responsibilities and Medical Information communication. “Medical Information Team is the first and sometimes the only contact point for patients/customers/HCPs and therefore, often the face of a company.” he added. 

The week-long event also saw Dr. Vivekanandan Kalaiselvan, Senior Principal Scientific Officer, Indian Pharmacopoeia Commission, Ghaziabad, and Ms. Nupur Goel, Pharma Research Professional preside over as key guest speakers. Ms. Nupur Goel delivered a talk on “Pharmacovigilance: An understanding and career options”, wherein she briefed different steps of PV, Detection, Assessment, Understanding and Prevention. She also explained Basic terms in ‘PV’ such as ICSR Individual Case Safety Report, Adverse Drug Experience (ADE, AE, ADR), Serious Adverse Event (Seriousness, Severity), PSUR, Association, Causality assessment, Causal Relationship, Vigiflow, Vigibase etc. 

Dr. Vivekanandan Kalaiselvan, who delivered a session on the topic: “Materiovigilance Programme of India: Roles and responsibilities of Pharmacy professionals”, elaborated on the role of Indian Pharmacopoeia Commission that obtains scientific data, analyses and communicates it to the regulating authority. Now, all medical devices are regulated by the Central Drug Standard Control Organisation. “Under the Medical Devices Rule of 2017, all medical devices are approved as drugs”, he said. He also added the signals and alerts data recently obtained for drugs such as Valproic acid in pregnant women and Miltefosin in Leishmania PKDL patients that causes ocular toxicity.

On day 4 of the week-long event students created different posters on the theme. 

An engaging talk session was delivered by Ms. Bharti Khanna, Founder Director, Amaranth Life Sciences Pvt Ltd. on the topic “Regulatory Requirements: Generic and Biosimilar Products”. She started the session with Origin of Regulatory Affairs with Sulfanilamide elixir tragedy in the USA (1937) and Thalidomide tragedy in Europe (late 50’s). The Role of Regulatory Affairs as interface between the pharmaceutical industry and Regulatory Authorities/Agencies was also discussed. 

During the week-long event, cultural extravaganza including nukkad natak, dance performances and so on were also showcased by students, who are also budding medical professionals.  

The final day of the event concluded with the Valedictory ceremony during which Prof. R.S. Dhankar, Vice Chancellor at Apeejay Stya University delivered his words of wisdom. Other guest present was Dr. Vishal Wahane, Senior Manager Medical Services, Walter Bushnell Pvt Ltd.

Marking the success of this grand event, a prize distribution ceremony was also held. The event ended with the National Anthem and Vote of Thanks extended by Dr. Mohini Kalra.

Harshita is Assistant Editor at Apeejay newsroom. With experience in both the Media and Public Relations (PR) world, she has worked with Careers360, India Today and Value360 Communications. A learner by nature, she is a foodie, traveller and believes in having a healthy work-life balance.

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