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US Regulatory Affairs: A Comprehensive Review of Regulatory Procedures for INDs and NDAs in the US

Nov 6 2013 8:00AM - Nov 8 2013 5:30PM | Mercure Paris la Villette 216 Avenue Jean Jaures 75019 Paris France

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As drug development becomes a global process, have you had questions about US Regulatory requirements? Do you wonder why your US colleagues ask for certain documents or information? This course is speci?cally designed for persons with a background in pre-clinical research (e.g., pharmacology, toxicology, and drug metabolism), clinical research, quality assurance or academia, with novice to intermediate experience in Regulatory Affairs, who need knowledge of the US regulatory processes. This course will also enhance understanding and be bene?cial to persons who work in clinical research, data management, biostatistics, basic research, project management and marketing, etc. DIA Europe also welcomes attendance by regulatory agency staff members. Participants need to have some knowledge of the ICH and in particular the Common Technical Document (CTD). Participants will gain a better understanding of the US regulation of investigational new drugs (INDs) and biologics, of the basics of submission of applications seeking marketing approval for a product and post-marketing regulatory requirements in the US.

What You Will Learn 

    • Regulation of drugs and biologics: The basics
    • Overview of the FDA
    • Regulatory requirements for drug development and approval
    • The IND - A general introduction
    • The IND - In detail
    • IND Amendments and maintenance
    • Procedures for reporting Adverse Events (AEs) that occur during clinical investigations
    • Submitting the NDA in CTD format – What’s unique to FDA
    • Post-approval regulatory requirements for NDAs
    • Interactions with FDA
    • US regulatory requirements for advertising and labelling
    • Regulatory compliance and FDA Inspections: What to expect after submitting the NDA
    • Navigating the FDA on the internet

    Learning Objectives 

      At the conclusion of this course, participants should be able to:

      • Define the key principles and processes used by the US Food and Drug Administration (FDA) in regulatory submission and approval.
      • Define official regulatory policies and other issues pertinent to a successful US regulatory strategy
      • Describe major differences between US and EU regulatory requirements
      • Describe the requirements for marketing applications for drugs and biologics , New Drug Application (NDA) and Biologics License Application and document preparation.
      • Recognise FDA oversight and processes during the post-approval phase.
      • Interact appropriately with the FDA during all phases of drug development
      • Understand the regulatory requirements for prescription drug labelling and advertising/promotion and differences with EU requirements.

        This course will focus on drug and biologic products; the regulatory process for devices or multisourced (generic) products will not be addressed.

        Hotel & Travel 

        DIA has blocked a limited number of rooms at the following hotel:

        Mercure Paris la Villette

        216 Avenue Jean Jaurès

        75019 Paris


        Tel:+33 (0) 1 44 84 18 18

        Fax:+33 (0) 1 44 84 18 20

        Email: mercureparisv@alliance-hospitality.com

        Website: http://www.mercure.com/fr/hotel-8816-mercure-paris-la-villette/index.shtml

        at the rates of:

        EUR 180.00 per room inclusive of breakfast and VAT.

        To make your reservation, please use the hotel booking from available on this link.

        Important: The room rate is available until 22 September or until the group block is sold-out, whichever comes first.


        Cancellation policy for bedrooms:

        No change or cancellation can be made after booking.

        The client acknowledges that first night of the stay will be charged when the booking is made.

        Contact Information 

        DIA Europe
        Kuechengasse 16, Postfach
        4002 Basel

        Tel.: +41 61 225 51 51
        Fax: +41 61 225 51 52
        Email: diaeurope@diaeurope.org


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        Registration Fees 


        Charitable Nonprofit/Academia Member
        Member Standard
        NonMember Government


        Charitable Nonprofit/Academia Nonmember
        NonMember Government
        NonMember Standard
        Register Online

        CANCELLATION POLICY: All cancellations must be made in writing and received at the DIA office five working days prior to the event start date. Full event cancellations are subject to an administrative fee:

        • Industry (Member/Non-member) = €200.00
        • Academia/Charitable/Government /Non-profit (Full-Time) (Member/Non-member) = €100.00
        • Tutorial cancellation: €50.00

        If you do not cancel five working days prior to the event start date and do not attend, you will be responsible for the full registration fee. DIA reserves the right to alter the venue and dates if necessary. If an event is cancelled DIA is not responsible for airfare, hotel or other costs incurred by registered attendees. Registered attendees are responsible for cancelling their own hotel and travel reservations.

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