Global Pharma Regulatory Affairs

Workshop Overview

This Two – Days event will provide a basic, but a comprehensive overview of Overall Global Pharmaceutical Regulatory-Affairs in a relaxed and interactive environment, yet complete focus on Quality, Safety, Efficacy and Market Driven Targets’ . The aim shall also be to touch basis Laisioning with various Ministry of Healths (country-specific FDAs)

What’s in it for you?

The event will elite you with the opportunity to learn about UK-MHRA and European Regulatory Affairs EMEA direct from the source. (as Dr Vandana worked with them 12 years directly day-in and out) This online face visual event will provide an basic overview of regulatory requirements, dossier making, CTDs, variations, strict ordinances, yet the considerations & waivers for product registration approvals qand sales in Regulated & Semi-Regulated Territories; being situated based in India The event training will touch-basis on all the inter- and intra- related Department activities, coordination and Time management. “CLOCK and HARMONISATION are the jargons”. The event will enhance to demonstrate how Regulatory is a Central-Semantics to almost all departments in company and outside in Vendor, Business, marketing, sales, Quality and yet Pharmacovigilance field. Case studies will be the forte of the 2 day event.

key highlights

Complete indepth working explanation including Annexes OF CTD
Qualified reports detailed explanation of clinical, nonclinical and QOS
UK MHRA and The EU EMEA Variations and Renewals
Latin America, Countries discussion
Labelling, SmPC, harmonistion, Market supplies and sales
EU cGMP Regulatory inspections
Overview of various Global Regulatory bodies and The Ministry of Health (MOHs)

: Trainer :

Dr. Vandana Jolad Shivanagi

Global Regulatory Business Director, VIaTAL Pharma

Dr. Vandana Jolad Shivanagi

Global Regulatory Business Director, VIaTAL Pharma

Organizations worked

Dr.Vandana Jolad Shivanagi is currently The Founder Director of VIaTAL Pharma for Global Regulatory, Technical, Pharmacovigilance, GMP audits, Training and Business strategy solutions, based in Mumbai.

Dr. Vandana has actually worked directly inside the UK and EU regions for nearly 14 years experience in Senior Management Regulatory, QA-related to Regulatory, plant-audits, Pharmacovigilance, clinical/biosimilars. Has closely worked with all EMEA/MHRA- authorities and successful getting several approvals, CEPs, variations and in taking company business ahead.

Dr.Vandana is an expert with semiregulated and unregulated markets as well and has personally visited Ministries of Health in various countries.

Dr Vandana is a Ph.D from University of Leeds, UK and B-Tech- from UDCT, Bombay, with an overall Pharma fine chemicals industrial operations and Regulatory affairs total experience of 29 years in Europe,Global , USFDA, LATIN, semi and regulated and in India.

The exposure to different country Regulatory Authorities and its link to Indian growth in has given her a wide perspective of the operations pharma- industry, getting product on sales and training

Dr. Vandana has formed and setup UK companys’ Regulatory and Pharmacovigilance department from scratch and got approval for the companys first MHRA/EU PV inspection.

Dr. Vandana is, herself a IRQAO-ASCB-UK approved LEAD Head Auditor of ISO-9001, EU /US cGMP , ICH7a. Getting Technical and Global Regulatory affairs approvals, clearing CTD/E-CTD dossiers from all Ministry of Healths & parallel skilled practical operations training of all above in are Dr.Vandanas’ forte. TOPRA, BARQUA, MeDrA global and Indian journals are the prime. She is active panelist , moderator of almost many global CPhI summits, conferences. etc