Advanced Vaccine Vigilance - US edition MasterClass

18-19 September, 2023

The vaccine vigilance gap in poor countries needs to be addressed.

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

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Pharma Online MasterClass

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.

#masterclass     #glceurope      #pharmaonlinetraining      #globalleadingconferences       #vaccinevigilance

 
Trainer
Dr. Subodh Bhardwaj, MD (AMU) RAC, BCMAS, RAPS (USA)
Dr. Subodh Bhardwaj, MD (AMU) RAC, BCMAS, RAPS (USA)
Senior Consultant Clinical Research/PV
Inventprise Inc, WA, & New York
Subodh Bhardwaj is a Physician and Clinical pharmacologist with 3 decades of experience in the Bio-pharmaceutical Industry leading Clinical research, Pharmacovigilance and regulatory affairs of Vaccines, Biologicals and Monoclonals. He qualified MBBS from Govt Medical College Jammu (1981) and MD Clinical Pharmacology from the prestigious JNMC, AMU, India in (1990). His certifications include-BCMAS (USA) 2019 & RAC (USA) 2022 & RAPS (USA) 2020. He was conferred a Diploma in Pharmacovigilance from Sanofi Pasteur, Lyon, France (2008) and is a global expert on Pharmacovigilance of vaccines and drugs and has conducted investigations with the WHO Biologicals. He worked as Medical Director of Serum Institute of India & Sanofi Pasteur/Aventis, Surgipharm Uganda- contributing to the licensing & safety assessment of Vaccines, through different phases of development- positively impacting public health at the global level. He worked as Senior Director Regulatory, with the International AIDS Vaccine Initiative (IAVI), New York on HIV antibodies, COVID-19 vaccines during the current pandemic. He also licensed the AH1N1 pandemic swine flu vaccine of Sanofi Pasteur in 2010 and chaired International Conferences on Pharmaco-vigilance in London in 2015 and 2018. He has researched and licensed more than 25 vaccines through clinical research & conducted Immunization campaigns in India, Egypt, Turkey, Iran, Algeria, Russia, Chile & Ukraine. He is member of BRAPP, ISoP and has 60 publications to his credit. He is currently based in New York and working on new Innovative vaccines.

Who should attend imgRECOMMENDATION

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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10+

Years of experience

299

Events organized

3,410

Speakers

17,761

Attendees

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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