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

Who Will Benefit

Pharmaceuticals Industry

  • Managers - Regulatory
  • VPs /CEOs international business
  • Support Regulatory Staff
  • Decision Makers
  • Business Development
  • Executives - Regulatory

Save The Dates

22 & 23 July 2021

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