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Starting 23 November 2020

3-week online academy

Develop your understanding of EU and US regulations for generics to ensure swift approvals and maximise generic market share potential

Course Overview

Bringing a generic drug to market can be fraught with regulatory challenges and compliance issues. Alongside the high amount of competition amongst generics companies looking to launch the same off-patent drug to market, commercial and financial pressures leave no room for inefficiency. All this considered, it is important for the regulatory process to be swift in order to keep costs down and ensure market share for your product.

This 3-week course will give you an overview of the generics market, current trends and practices enabling you to build strategies for regulatory compliance.

Online Academies

Pharmaceutical Training International online courses are on-demand digital courses developed by our expert faculty providing learning on a range of technical topic areas.

Over 3 weeks students will learn through:

  • 6 modules, split up into multiple bitesize recorded videos
  • Quizzes to test your knowledge
  • Revisiting the content with unlimited access to all the materials for 3 months
  • Participating in the discussion forum to interact with other students
  • Interacting with the trainer through the forum during the course
  • Additional content such as materials and white papers available to download

Delegates will receive login instructions within a week of the course start date. If you have any questions please contact

What will you learn?

EU and US regulations
EU and US regulations

Work through the laws and regulations governing the registration of generics in EU and US

Abbreviated New Drug Applications (ANDAs) submissions
Abbreviated New Drug Applications (ANDAs) submissions

Submit ANDAs by understanding the critical elements

Key requirements
Key requirements

Meet the key requirements and understand the different submission types

Development plans
Development plans

Create the development plan for "Right First Time" generics

Key developments
Key developments

 Assess the major developments in patents and trademarks for global generics

Market exclusivity & patents
Market exclusivity & patents

Understand key developments in market exclusivity and patents

ANDA submission management
ANDA submission management

Know how to manage ANDA submission to achieve its approval and its life-cycle management

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

Find out more about online academies...

PTI online academies are perfect for busy professionals as they require just 2 hours per week of your time, and include an interactive forum for you to ask direct questions about challenges you are facing to expert course leaders.

On average, delegates of our online academies said...

for quality of content
applied content during course to their role
for quality of delivery

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.