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Mastering Regulatory and Development Strategies for Generics

27 - 28 November 2018

Radisson Blu Edwardian Kenilworth, London

Agenda

Strategic insight into key requirements for developing generics from
a global perspective

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Bringing a generic drug to market can be fraught with regulatory challenges and compliance issues. This course will allow the participants to gain a strategic insight into key requirements for developing generics from a global perspective and an overview of the generics market; current trends and practices; and future strategies for regulatory compliance.

Examine the impact of EU and US regulatory approval for generic products
Clarify the criteria for submitting generic applications in Europe and US
Enable creation of development plan for "Right First Time" generics
Assess the major developments in patents and trademarks for global generics
Maximise generic market-share potential
Formulate regulatory strategies to achieve successful regulatory performance and compliance
Pinpoint key developments in market exclusivity

Andrew Willis

Previously Vice President of Regulatory Affairs and Consulting Services at Catalent Pharma Solutions, Andrew is currently an independent regulatory affairs and pharmaceutical development consultant. Andrew has over 28 years of experience in regulatory affairs and pharmaceutical development, with specific experience of EU and US registrations, CMC regulatory requirements and multiple clinical aspects related to successful registration of drug products. Andrew is considered an expert in lifecycle management and has signifi cant experience in OTC and generic development, as well as global development strategies.

This course has been specifically designed to address the needs of:

Regulatory Affairs Managers/Officers/ Assistants
Compliance Managers
Product RegistrationPersonnel
Project Managers in Regulatory Affairs
Documentation Managers
Key contributors to submission procedures

Strategic insight into key requirements for developing generics froma global perspective

Andrew Willis

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Strategic insight into key requirements for developing generics from
a global perspective