Global Pharma Regulatory Summit

25 May - 28 May 2021

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Workshop Overview

CPhI Conferences and Informa Markets in India are delighted to announce the 10th annual Global Pharma Regulatory Summit as a virtual conference. A premier pharma regulatory event for the generics and biosimilars industries, featuring timely programmed and relevant to technical and regulatory agenda. This summit will bring together pharma regulatory operations and submission professionals to learn best practices in the compilation, formatting and submission of a variety of approval applications. Top officials and subject-matter experts will share their knowledge and best practices on how to succeed in generic and biosimilar development, the regulatory process and approvals and the evolving policy landscape.

Program Focus

Regulatory Affairs in New Normal

Product Lifecycle Management

cGMP

Biosimilars

Nitrosamine

Impurity Profiling

Emerging Markets

Emergency Use Authorizations

Product Lifecycle Management: ICH Q12

cGMP Inspections Amid COVID-19 Pandemic

Remote Personal Interactions

Biosimilars in EU

Emerging Markets – China, Japan, Africa and Canada

Nitrosamine Testing: The Regulatory Aspects

eCTD Preparation and Submission

Benefits of Attending

Access the latest information and insights on global regulatory affairs program

Analyze how stakeholders around the world are supporting regulatory system optimization

Examine the impact of new initiatives for emerging markets

Network with innovators and opinion leaders in the pharma regulatory affairs arena

Who Should Attend?

The Global Pharma Regulatory Summit is designed for

Regulatory Affairs
Compliances
Policy Makers and Strategists
Quality Assurance and Control

Designations

VP’s / Directors / HODs
Sr. Managers / General Managers
Managers / Deputy Managers
Executives

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