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US Regulatory Affairs

Nov 5 2014 8:00AM - Nov 7 2014 6:30PM | Holiday Inn Bloomsbury Coram Street London WC1N 1HT United Kingdom

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Overview 

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 specifically designed for persons with a background in pre-clinical research (e.g., pharmacology, toxicology, 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 beneficial 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 (NDA & BLA) 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 key 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 (BLA) 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.

      Hotel & Travel 

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

      Holiday Inn London-Bloomsbury
      Coram Street,
      London, WC1N 1HT, United Kingdom
      Tel.: +44 8719429222
      Fax: +44 20804348
      Email: reservations-bloomsbury@ihg.com
      Website: www.hilondonbloomsburyhotel.co.uk

      at the rate of:
      GBP 165 per room inclusive of breakfast.

      To make your reservation, please contact the hotel directly at:
      Tel: +44 8719429222
      Fax: +44 20804348
      Email: reservations-bloomsbury@ihg.com

      Please quote the booking reference: ZOL

      Important: The room rate is available until 3 October 2014 or until the group block is sold-out, whichever comes first.

      Contact Information 

      Registration Questions
      Phone.: +41 61 225 51 51
      Fax: +41 61 225 51 52
      Monday-Friday 8:00-17:00 CET
      diaeurope@diaeurope.org

      Agenda and Event Logistics
      Magdalena Lewandowska, Event Manager
      Phone: +41 61 225 51 65
      Fax: +41 61 225 51 52
      magdalena.lewandowska@diaeurope.org

       

       

      Faculty 

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      Agenda  

      Day 1 Wednesday, Nov 05, 2014

      • 7:30AM - 8:00AM (GMT Standard Time)

        REGISTRATION
      • 8:00AM - 8:15AM (GMT Standard Time)

        WELCOME AND INTRODUCTION
      • 8:15AM - 9:15AM (GMT Standard Time)

        Session 1: INTRODUCTION TO REGULATION OF DRUGS AND BIOLOGICS
      • 9:15AM - 9:45AM (GMT Standard Time)

        Session 2: THE DRUG DEVELOPMENT PROCESS: AN OVERVIEW
      • 9:45AM - 10:15AM (GMT Standard Time)

        Session 3: THE IND - A GENERAL INTRODUCTION
      • 10:15AM - 10:30AM (GMT Standard Time)

        COFFEE BREAK
      • 10:30AM - 11:15AM (GMT Standard Time)

        Session 4: THE IND IN DETAIL - ITEMS 1-6
      • 11:15AM - 12:30PM (GMT Standard Time)

        Session 5: SPECIAL TOPICS FOR CLINICAL RESEARCH UNDER AN IND
      • 12:30PM - 1:30PM (GMT Standard Time)

        LUNCH
      • 1:30PM - 2:15PM (GMT Standard Time)

        Session 6: IND IN DETAIL - ITEM 7
      • 2:15PM - 3:00PM (GMT Standard Time)

        Session 7: IND IN DETAIL - ITEMS 8, 9 AND 10
      • 3:00PM - 3:15PM (GMT Standard Time)

        COFFEE BREAK
      • 3:15PM - 4:00PM (GMT Standard Time)

        Session 8: IND IN DETAIL - ADDITIONAL TOPICS
      • 4:00PM - 5:00PM (GMT Standard Time)

        Session 9: QUALITY ASSURANCE IN DRUG DEVELOPMENT (GXPS)
      • 5:00PM - 6:00PM (GMT Standard Time)

        DRINKS RECEPTION

      Day 2 Thursday, Nov 06, 2014

      • 8:00AM - 8:30AM (GMT Standard Time)

        Session 10: FDA’S ACTIONS ON THE ORIGINAL IND & FUTURE AMENDMENTS
      • 8:30AM - 9:45AM (GMT Standard Time)

        Session 11: ACTIVITIES AND SUBMISSIONS AFTER THE ORIGINAL IND
      • 9:45AM - 10:00AM (GMT Standard Time)

        COFFEE BREAK
      • 10:00AM - 11:00AM (GMT Standard Time)

        Session 12: REPORTING ADVERSE EVENTS (AES) DURING CLINICAL TRIALS
      • 11:00AM - 12:00PM (GMT Standard Time)

        Session 13: THE NDA IN CTD FORMAT
      • 12:00PM - 1:00PM (GMT Standard Time)

        LUNCH
      • 1:00PM - 2:30PM (GMT Standard Time)

        Session 14: THE NDA IN CTD FORMAT: WHAT IS A CTD?
      • 2:30PM - 4:00PM (GMT Standard Time)

        Session 15: THE NDA IN CTD FORMAT
      • 4:00PM - 4:15PM (GMT Standard Time)

        COFFEE BREAK
      • 4:15PM - 6:00PM (GMT Standard Time)

        Session 16: THE FDA AND RISK MANAGEMENT

      Day 3 Friday, Nov 07, 2014

      • 8:00AM - 9:30AM (GMT Standard Time)

        Session 17: THE NDA IN CTD FORMAT: HOW TO SUBMIT AND ACTION ON APPLICATIONS
      • 9:30AM - 9:45AM (GMT Standard Time)

        COFFEE BREAK
      • 9:45AM - 11:15AM (GMT Standard Time)

        Session 18: POST-NDA APPROVAL REGULATORY REQUIREMENTS
      • 11:15AM - 12:30PM (GMT Standard Time)

        Session 19: INTERACTIONS WITH FDA
      • 12:30PM - 1:30PM (GMT Standard Time)

        LUNCH
      • 1:30PM - 3:00PM (GMT Standard Time)

        Session 20: MOCK FDA MEETING
      • 3:00PM - 3:15PM (GMT Standard Time)

        COFFEE BREAK
      • 3:15PM - 4:00PM (GMT Standard Time)

        Session 21: REGULATORY COMPLIANCE AND FDA INSPECTIONS: WHAT TO EXPECT AFTER SUBMITTING THE NDA
      • 4:00PM - 4:45PM (GMT Standard Time)

        COURSE ASSESSMENT
      • 4:45PM - 5:30PM (GMT Standard Time)

        Session 22: REGULATORY REQUIREMENTS FOR PRESCRIPTION DRUG LABELLING & PRESCRIPTION DRUG/BIOLOGICS ADVERTISING AND PROMOTIONAL LABELLING

      Registration Fees 

      Member

      Charitable Nonprofit/Academia Member
      €920.00
      Member Standard
      €1840.00
      NonMember Government
      €920.00

      Non-Member

      Charitable Nonprofit/Academia Nonmember
      €1050.00
      NonMember Government
      €1050.00
      NonMember Standard
      €1970.00
      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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