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conferenceseries.com
Volume 7, Issue 5 (Suppl) J Clin Trials, an open access journal
ISSN:2167-0870 Clinical Trials 2017
September 11-13, 2017
September 11-13, 2017 San Antonio, USA
4th International Conference on
Cl inical Tr ial s
PVG and drug safety- pharmacovigilance in India and emerging markets: An industrial perspective
Ujwala V Salvi
Nucleon Therapeutics LLP, India
Development and implementation of evidence-based, public-health focused, collaborative, globally electronic and
regulatory compliant approach is need of hour to gain comprehensive Pharmacovigilance (PV) system. The authors
discuss development of a model for uniform PV data input-output across industry. Authors contemplate data collection; data
analysis; data processing; medical review and data distribution systems as basic PV process. Data collection systems should
include detailed process of collecting various adverse events (AEs) from literature searches, healthcare professionals (HCP),
non-HCP, spontaneous, clinical trials, patient registries, post marketing surveillance etc. Data should be processed in CIOMS
form I by using ARGUS, ARISg, MedDRA, WHO drug dictionary and company drug repository or local regulatory AE
form, etc. It should be medically reviewed followed by distribution to respective regulatory authorities where thorough signal
identification, prioritisation and investigation will be performed. Signal detection can be done by using Medline/PubMed,
Springer, OVID database, reactions weekly, local publications etc. Non-english cases/literature reports should be translated to
english via authorised vendor or in-house translation system. Safety data from license partners and third party manufacturers
should be collected and processed by maintaining safety data exchange agreements (SDEA). PV model can be fully in-house
end to end or part in-house and part outsourced or fully outsourced. In conclusion, an effective implementation of PV activities
like robust PV systems, signal detection and SDEAs could definitely yield robust patient safety data from India and emerging
markets.
Biography
Ujwala V Salvi has over 15 years of experience across the globe and local Pharmaceutical/CRO, tier I Medical Devices and BPO industry. She has an MBA from
Indian Institute of Management, Kolkata and Doctorate in Applied Biology. She is trained in Six Sigma Black Belt and various project management tools, with core
experience in a wide range of therapeutic areas, and worked at all stages of clinical development from Phase II to production of clinical documentation necessary
for product license applications. She has worked in large global operations, managed strategic relationships, and played a key role in winning new business, setting
up off-shored partnerships and in identifying new BU service lines and growing existing ones. Her areas of expertise include clinical trial operations, risk based
monitoring, medical writing and data publication, clinical data management, and feasibilities of new drug development and analytics. She is an industry expert, has
been involved in key global industry forums such as the DIA, SCDM, CII and CPHI.
Ujwala V Salvi, J Clin Trials 2017, 7:5 (Suppl)
DOI: 10.4172/2167-0870-C1-019