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Informa
TBC in 2021

2-day course

Gain a strategic insight into the key requirements for developing generics from a global perspective

Course Overview

This puts greater emphasis on pricing strategy, with prices driven down to remain competitive and resulting in lower margins. It is therefore important for generic manufacturers to competently manage the regulatory approval and compliance process to keep costs down.

This 2-day course will provide you with 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. You will examine the process in the EU and US comparing and contrasting with examples and case studies. As well as learning about small molecules you will examine the regulatory procedures for biosimilars, the biological generic equivalent, which are growing year on year.

There will be time on this course to discuss the likely implications of Brexit on regulatory strategies for generics.

What will you learn?


EU and US regulations
EU and US regulations

Examine the impact of EU and US regulatory approval for generic products

Criteria for approval
Criteria for approval

Clarify the criteria for submitting generic applications in Europe and US

Produce a development plan
Produce a development plan

Enable creation of development plan for "Right First Time" generics


Patents and trademarks
Patents and trademarks

Assess the major developments in patents and trademarks for global generics

Key market developments
Key market developments

Pinpoint key developments in market exclusivity

Who is this course for?

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

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

CPD Certified

Engaging in Continuing Professional Development ensures that both academic and practical qualifications do not become out-dated or obsolete; allowing individuals to continually ‘up skill’ or ‘re-skill’ themselves, regardless of occupation, age or educational level. This course has been assessed and is CPD certified.