Live Online Training Course | 9am - 5pm CEST
Navigate the U.S. FDA regulatory landscape for drug application dossiers and gain a comprehensive understanding of how to ensure successful submissions
Including New Drug Applications (NDAs), Investigational New Drug Applications (INDs), Abbreviated New Drug Applications (ANDAs)
The US is the largest market for pharmaceutical and biotech products making access a key strategic goal for organisations. In order to take advantage of the market opportunity, it is imperative to gain speedy regulatory approval for your products to support the successful launch of a new innovator or generic therapy. Like all regulatory approvals, the US FDA process is challenging for professionals as you need to understand all the latest procedures to ensure a positive outcome.
This 2-day course will provide you with a comprehensive understanding of the US regulatory processes such as Investigational New Drug Applications (IND) and New Drug Applications (NDA). In addition you will gain an insight into the workings of the FDA review process and learn best practice for requesting information from the FDA Regulators. On completion of the course, you will have a practical insight into the FDA’s requirements for new drug development and drug registration dossiers. You will also learn how to prepare a generic drug submission for fast approval, crucial in the competitive generic market.
Live Online Training Course
Gain real-time access to a subject matter expert delivering online training in a structured virtual classroom environment.
Over 2 days students will learn through:
- Direct interaction with the trainer during live sessions
- Participation in interactive group discussion and Q&A
- Revisiting recorded sessions with unlimited access for 10 days
- Interaction with peers during live sessions and through the online forum
Timings and dates are subject to change - final confirmation will be provided with login details. Delegates will receive login instructions two days prior to the course start date. If you have any questions please contact firstname.lastname@example.org.
What will you learn?
Work your way through the laws and regulations governing the registration of prescription drugs in the US
Submit complete dossiers by understanding the critical elements of US INDs and NDAs
Submission review options
Define the best strategy for your submission pathway
INDs and different types of NDAs
Meet the data requirements for INDs, NDAs and ANDAs (generics)
Interacting with the FDA
Communicate better with the FDA by knowing its structure and the interactions within the agency
Maintaining NDAs successfully
Understand how to submit and follow post-approval activities
Who is this course for?
This course has been specifically designed to address the training needs of executives who are or will be involved in the preparation of development plans and/or registration dossiers.
- Regulatory Affairs
- Compliance Managers
- Documentation Managers
- Product Registration Personnel
- Project Managers in Regulatory Affairs
- Marketing Managers
- Clinical Research Personnel
- Key contributors to the submission package for the US market
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.