Day 2 :
New York & Inventprise, USA
Keynote: Driven strategy for effective monitoring pharmacovigilance quality system – key pointChallenges in pharmacovigilance of vaccines in clinical trials and risk management strategies
Time : 10:00-10:40
Subodh Bhardwaj, New York & Inventprise, USA
The global vaccine market size will touch 48 billion USD by 2025. With 15 new introductions this century millions of children and adults are being immunised globally. Research on new vaccines for HIV, Ebola, Zika, Dengue, Universal Influenza vaccines and yellow fever are in the pipeline. New manufacturing technologies, new routes of administration, advances in genomics, emerging disease pandemics & outbreaks, innovation and demand from emerging economies makes the vaccine segment profitable. Support from WHO, UNICEF, GAVI and Gates foundation has stirred new vaccine introductions in Asia, Africa e.g. Meningococcal, Pneumococcal vaccines. Vaccines have a high generic barrier and potential to generate blockbuster sales e.g. Shingrix. Vaccines differ from drugs as they are preventive while drugs are curative. Increased demand has necessitated increasingly stringent safety requirements during preclinical, clinical and post licensure thereby making vaccine vigilance and risk mitigation more precise to be able to pre-empt detection, assessment, analysis and prevention of new SAEs or SUSARs, to make vaccine recipients safe. The author discusses case reports to reinforce effective methods and outcomes. The immunization and pharmacovigilance gap needs to be addressed globally as 50% of 20.8 million unvaccinated children are from South Asia & Africa with poor PV facilities. Though 20.4 million deaths have been prevented by Measles vaccine from 2000-2016, yet 254 children die each day! It costs only 2 USD to protect a child against Measles, rubella in developing countries. There is need for enlarging the pharmacovigilance perspective with better understanding of vaccine components, linkage to clinical trials, increased awareness, PV concepts, pitfalls- as a child receives 37 shots from birth through 6 years of age & vaccine safety has a very narrow margin for error.
Food and Drug Law, Brazil
Time : 10:40-11:20
Eliana Silva de Moraes has her expertise in food and drug law. Twenty Six years’ experience helping international pharmaceutical, health and food companies to gain presence in markets of Latin America and Europe, specially. She has an active participation in the harmonization of regulatory affairs process through the organizations that she represents, ABPVS. Played an active role in setting up Brazil’s Public Health Regulator (ANVISA), organizing the agenda of its first Anvisa’s President in USA in order to explore the US specially the Food and Drug Administration (FDA) and Paho, in December 1998. President of the ABPVS a Regulatory Affairs Organization for Brazil and Latin America Countries and Lawyer at Silva de Moraes. Member of the Brazilian Bar Association and The Portugal Bar Association. Speaks Portuguese, English, French and Spanish
A medicinal product is authorised on the basis of the benefit-risk judged at the time of approval process registration. Besides, pharmaceutical companies need to deal regularly with necessary measures to mitigate risks and preserve the benefits of the product specially when working in a global market. Transforming risk management concepts into regulatory actions is crucial for a successful pharmaceutical projects. This presentation will cover the recent and relevant laws, international standards, and regulations contributing to the achievement of the essential tools to treat risks and evaluate the pharmaceutical products benefits; comprehensive survey of legal benefit-risk definition; evaluation and control of the registration approval process globally. Identification and analysis of different tools in the legislation to controls the risk; critereas for risk evaluation such as clinical trial, pharmacovigilance and other important procedures.