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 a successful launch of a new innovator or generic therapy. Like all regulatory approvals, the US FDA process is challenging for professionals to navigate 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.
Regulatory and Development consultant with 30 years of experience. Andrew’s management roles have seen him act as global Vice President of Regulatory Affairs and Medical Affairs, creating business and marketing strategies for complex pharmaceutical development projects. Andrew has gained therapeutic experience in areas covering CNS, oncology, urology and pain management.
Experienced with both EU and US applications (NDA, 505 B 2, ANDA, BLA, MAA) for NCEs, generics and line extensions, with particular knowledge of sterile and biotech products. Experience covers multiple applications, scientific advice meetings, Clinical Trial applications (IND and IMPD compilation and submission), orphan drug applications. Significant Experience with novel drug delivery systems has been utilized in all of the above type of applications.
Andrew continues to provide training for all major companies and also a number of EU Member states agencies in CMC, variations and advanced regulatory affairs. He currently delivers extensive training courses available in Quality By Design, Global Module 3 Requirements, global generic development and Optimizing the Life of Your Products. Specializing in Lifecycle management, creation of new line extensions and development strategies to maximize return on investment.
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.
We're looking forward to welcoming our attendees and expert course leaders at US-FDA Drug Submission Procedures in London in March.
Our number one priority is the safety of our delegates and colleagues, and there are always measures in place at our venues to safeguard your health and safety. There are extra measures in place for 2020 in light of developments with COVID-19.
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