The US is the largest market for pharmaceutical and biotech products making it 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 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 Academies
Gain real-time access to a subject matter expert delivering online training in a structured virtual classroom environment. Live online academies are virtual versions of some of our most popular face-to-face courses.
Students will learn through:
- Live interactive sessions
- Direct interaction with the trainer during live sessions
- Participation in interactive features within sessions including polls, Q&A, break out rooms, tasks, case studies, and more
- Revisiting recorded sessions with unlimited access for 30 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 within a week of the course start date. If you have any questions please contact email@example.com.
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
INDs and NDAs
Meet the data requirements for INDs and NDAs
Interacting with the FDA
Communicate better with the FDA by knowing its structure and the interactions within the agency
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.
- 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
Delegates of our live online academies said...
would attend another live online academy
found the course beneficial to their day to day role
would recommend the course to others
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.