Tougher regulatory approval processes pose potential set-backs for pharmaceutical companies registering drugs in the USA . . . can you afford to waste your R&D investment by delaying your product launch? In the challenging environment of US drug registrations procedures, you and your colleagues need to understand all the current procedures. To help you do this, PTI has developed this course that will clarify the US regulatory process. By attending this extensive two day course, you will gain a practical insight into the FDA’s requirements for new drug development and how to prepare your new drug registration dossier according to US guidelines.
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.