Startdate:
6 October 2010 - 8 October 2010 Purpose:
The aim of this module is to ensure an understanding of how to best develop and gain approval for a new drug or biological in the USA with emphasis on the requirements for development and maintenance of new drugs. During drug development the sponsor should interact with the Food and Drug Administration (FDA) on a regular basis to gain agreement on the best program of studies to provide the data required by the agency to demonstrate the efficacy and relative safety of the drug for the proposed indication. In addition the sponsor must demonstrate that the drug meets the quality standards required for approval. There are also various programs available that may be used to speed drug development and regulatory approval if requested by the sponsor and agreed to by the agency. The course will go into detail on how to interact with the various Centers at the FDA specific for Drugs (CDER) and Biologicals (CBER) from early non-clinical and clinical research to post-approval obligations. The course will provide the participants with detailed knowledge of US specific documentation requirements and where relevant compare and contrast these to EU and ICH guidelines and requirements. Content:The regulatory processes, legal requirements, agency interactions during development and preparation of INDs, NDAs and post-approval documentation in the USA. - Organization of the Food and Drug Administration and Introduction to Legal Basis of Regulatory Affairs in the US
- Overview of Various Regulatory Submissions
- Communication with the FDA during Development
- The Investigational New Drug Application / Clinical Requirements
- The Investigational New Drug Application / Non-Clinical Data Requirements for the IND and NDA
- The Investigational New Drug Application / Quality Section for the IND and NDA
- The Investigational New Drug Application / Quality Section for the
- IND and NDA (Biologics and Biotechnology Products
- Fast Track Development, Accelerated Approvals, Orphan Drugs
- Labelling and Advertising Regulation
- NDA/BLA – Content, Format and Review Process
- Communication with the FDA Prior To NDA Submission, During Review and Post-Approval
- FDAMA, PDUFA I-IV and FDAAA
- Life Cycle Management: NDA/BLA
- Regional Differences between EMEA and the FDA
- ANDAs
Course Leaders:
James L. Hinson, Myriad Pharmaceuticals, Salt Lake City, Utah, US
Thomas Donnelly, PhD, Donnelly Regulatory Consulting, LLC, Langhorne, PA, USA Lecturers:
Wayne Pines, APCO Worldwide, US
Robert Babilon, Graceway Pharmaceuticals LLC US
Thomas Donnelly, PhD, Donnelly Regulatory Consulting, LLC, Langhorne, PA, USAJames L. Hinson, Myriad Pharmaceuticals, Salt Lake City, Utah, US
David Christ, PhD, Pre-Clinical Development Consultant, SNC Partners, LLC, US
Donald G. Esherick, Director, CMC, Global Regulatory Affairs, Wyeth Research, Collegeville, PA, USA
Suzanne Sensabaugh, PhD, Founder & Member, HartmannWillner LLC, King of Prussia, PA USA
Chris Lester, Eli Lilly and Company Limited, UK Prerequisites:In order to secure the professional level of the education. The participants must have a educational background at bachelor level within a relevant area and at least two years’ experience within Regulatory Affairs or equivalent qualifications. Please note that applications will be considered in order of receipt. Medicademy accept up to 10 - 20 % of the seats at a module to be occupied by applicants who have none or limited experience within the regulatory affairs area. These participants must have experience within the pharmaceutical/biological area that qualify them to benefit from the training and to participate actively during the module. The participation will be considered on a case-by-case basis. Literature:
A list of recommended literature will be send to the participants approx. 4 weeks prior to the start of the module.
The list will be divided into mandatory and optional reading. The mandatory references is part of the examination syllabus.
The participants are expected to study and be familiar with the mandatory references in advance of the module. |
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Price:DKK 17,000.00 (approx. EUR 2,555.00) + VAT 25%, all inclusive, e.g. accomodation, meals, course material Exam fee DKK 1,500 (approx. EUR 202) Cancellations must be in writing and must be sent to Medicademy. Cancellations later than two weeks prior to the course, a cancellation fee of 50% of the course fee is charged. Cancellations one day before or on the day of the course, a cancellation fee of 100% of the course fee is charged. A booked seat can be transferred to another qualified participant free of charge. In the event of circumstances beyond our control, Medicademy reserves the right to change the programme, lecturers, dates or venue, if necessary. If Medicademy cancels a course, the course fee will be fully reimbursed. Registration deadline:
29 September 2010 Exam:Date of examination: November 12, 2010 You can tak the exam in your own country! Medicademy arrange examinations at Embassies, Universities etc. all over the world. Information about examination form etc. will follow. Remember to register for the exam separately! |
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Register:
DKK 17,000.00
VAT, 25% DKK 4,250.00
Incl. VAT DKK 21,250.00
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