Advanced Vaccine Vigilance - US edition MasterClass
18-19 September, 2023
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.
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
Testimonial
Our success stories
"High attention to detail in course content and very well delivered"
Simon Halsey
Product Development Manager
Essentra Packaging
United Kingdom
Our success stories
"Very good training led by two knowledgeable and open experts. Excellent insight given on many complex topics. Interactive and highly useful"
Aurelie Vivicorsi
USP PD Team Manager
Celonic AG
Switzerland
Our success stories
"Great course, impressed with the knowledge of the trainers and ability to answer wide variety of questions!"
Emilia Szwej
Manager, Senior Investigator
MT Sword Laboratories (BMS)
Germany
About GLC
Global Leadership Conferences began as an ambitious dream by three founders ten years ago. Today it’s an international series of interactive events, exploring the hottest topics in critical fields. Each year, thousands of professionals join us to challenge the status quo and learn innovative ways to create new solutions in Finance, Pharmaceutical, HR, Health & Safety, and Energy.
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