Advanced Vaccine Vigilance - US edition MasterClass

The current masterclass is organized to provide a brief but important overview to assess the basics and critical components of PV system of vaccines, recent changes in regulatory requirements in the US and EU, role of International agencies in biologics safety with real world evidence examples.

18-19 September, 2023, Virtual

Time Zone: Eastern Standard Time (EST) / UTC−05:00

Overview

Vaccine vigilance is a science to evaluate vaccine safety in pre-clinical, clinical and post license settings through out the products life cycle. The global vaccine market was 187 billon US dollars in 2021 (137 billion USD for Covid vaccines!). It has a CAGR of 10.8% predicted for North America and Asia pacific regions. Newer vaccine introductions like Covid-19, Lassa virus, Pneumococcal conjugate, Malaria, HPV need more stringent pharmaco-vigilance and risk mitigation measures. Large sample size clinical trials with Covid-19 vaccines on 3000 subjects (USFDA) reinforce the need to detect Adverse events, SAEs, SUSARs, signals and causality more stringently with better methods utilizing INSIS (International network of special immunization services) launched by the Brighton Collaboration as an international, multidisciplinary group to investigate rare AESIs. ADVERSOMICS, is a new concept that enables application of system biological tools to study scientific basis for differences and characterize pathogenesis of AESIs. The vaccine vigilance gap in poor countries needs to be addressed. The current masterclass is organized to provide a brief but important overview to assess the basics and critical components of PV system of vaccines, recent changes in regulatory requirements in the US and EU, role of International agencies in biologics safety with real world evidence examples. The attendees from the vaccine industry, CROs, Research workers, Medical and Nursing schools associates and senior personnel in Clinical research, regulatory or Drug safety physicians are likely to benefit from this advanced Masterclass.

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RECOMMENDATION

Who should attend?

• PV Executives (Vaccine industry)

• Contract Research Associates

• Academia involved in PV

• Research Associates

• Clinical development

• Vaccine safety Physicians

• Regulatory affairs

• Nursing executives in PV

• Associate directors & Directors

• Beginners in Vaccine vigilance