Course description
Regulatory Guide to the Generics Market
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.
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Suitability - Who should attend?
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
Outcome / Qualification etc.
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.
Training Course Content
- Module 1: Introduction and current overview of the European generics market
- Module 2: Overview of US generics submission strategies
- Module 3: Overview of European submission strategie
- Module 4: EU submission Examples and case studies
- Module 5: Overview of patents and trademarks for global generics, EU, US, Key requirements for developments for global generic authorisations
- Module 6: What are the potential regulatory challenges facing the Biosimilars / Follow-on Biologics market?
Course delivery details
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:
- 9 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
Why choose PTI
On average, delegates of their online academies said:
Quality of content:
4/5
85% had applied content during the course to their role
Delivery rating:
4/5