Startdate:
10 April 2013 - 12 April 2013

Purpose:
The module aims to ensure a general understanding of how to best develop and gain approval for a new drug or biologic in the USA with emphasis on the requirements for development and maintenance of new drugs. During drug development, sponsors must interact with the Food and Drug Administration (FDA) on a regular basis in order to gain agreement on the best programme of studies and thereby provide the data required by the Agency to demonstrate efficacy and safety of the drug for the proposed indication. Further, sponsors must demonstrate that the drug meets the quality standards required for approval. Also, there are various programmes available, which may be used to speed drug development and regulatory approval, if requested by sponsors and agreed to by the Agency.

The module will go into detail on how to interact with the various Centers at the FDA, including the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER), from early non-clinical and clinical research to post-approval obligations. The module will provide the participants with a detailed knowledge of US-specific documentation requirements, and - when relevant - compare and contrast these to the EU and ICH guidelines and requirements.

By the end of this module, the student should be able to:
• Understand drug development in the USA and play an important role in any project team working on drug development in the USA by use of their newfound knowledge on procedures and practices of the FDA

• Analyse and evaluate development plans in terms of the use of best practices required by the FDA, make recommendations on how to achieve project goals in the shortest development time, how to gain agreement with the FDA in order for the development plans to provide study results acceptable to the FDA, and how to present data and results in the NDA in order for the FDA to be able to readily determine whether efficacy and safety of the drug has been satisfactorily demonstrated. The regulatory professional will be able to provide valuable input to all other team members regarding development plans of the drug under study.

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

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.

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.

Accomodation (not included in the course fee):