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 and who have novice to intermediate experience in Regulatory Affairs, who need an enhanced knowledge of the US regulatory procedures. This course will also be beneficial to and enhance understanding of persons who are in Clinical Research, Data Processing, Biostatistics, Basic Research, Project Management, and Marketing, etc. DIA Europe also welcomes attendance by regulatory agency staff members. Attendees will need to have some knowledge of the ICH and in particular the Common Technical Document (CTD). Participants will gain a better understanding of the regulation of investigational new drugs and biologics, of the basics of submission of applications seeking marketing approval for a product, and post-marketing regulatory requirements.

TOPICS

• Role of the regulatory professional
• 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 Amendment
• Procedures for reporting Adverse Events (AEs) that occur during clinical investigations
• The NDA in CTD format
• 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

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.
• Describe the requirements for New Drug Application (NDA) and Biologics License Application and document preparation.
• Demonstrate an understanding of the NDA and the Biologic License Application (BLA) processes and CTD document preparation.
• Recognize FDA oversight and processes during the post-approval phase.
• Interact appropriately with the FDA during all phases of drug development including the application of good review management practices.
• Explain the regulatory requirements for prescription drug labelling and advertising/promotion.

Workshops are utilised in the course to augment the lectures. During such workshops, participants will work in teams on case studies and will present the results to other participants.

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

This course is designed for newly hired regulatory affairs professionals with backgrounds of less than six months’ experience or who are making a career change into regulatory affairs. The course will benefit those pharmaceutical industry professionals who are new to the Investigational New Drug Application (IND) process, New Drug Application (NDA) process and the Common Technical Document (CTD).

This course will also benefit professionals in clinical research, data processing, biostatistics, basic research, project management, and marketing, who would like to gain a better understanding of the regulation of investigational new drugs and biologics.


CANCELLATION POLICY

Cancellations must be made in writing and be received at the DIA Europe office by 17:00 CET on October 12, 2009
Cancellations received by the date above are subject to an administrative fee:

Industry (Member/Non-Member) = EUR 200.00 / Government and Academia (Member/Non-Member) = EUR 100.00

Registrants who do not cancel by the date above, and do not attend, will be responsible for the full registration fee.

Registrants are responsible for cancelling their own hotel and travel reservations. If an event is cancelled, DIA Europe is not responsible for airfare, hotel or other costs incurred by registrants. DIA Europe reserves the right to alter the venue and dates if necessary.

TRANSFER POLICY

You may transfer your registration to a colleague prior to the course start but membership is not transferable. Substitute registrants will be responsible for the non-member fee, if applicable. Please notify the DIA Europe office of any such substitutions as soon as possible.

EUROPEAN BRANCH OFFICE

ELISABETHENANLAGE 25

POSTFACH

4002 BASEL

SWITZERLAND

PHONE: +41 61 225 51 51

FAX: +41 61 225 51 52

E-MAIL: DIAEUROPE@DIAEUROPE.ORG

The DIA has blocked a limited number of rooms at the:

Ramada Plaza Basel Hotel
Messeplatz 12
4058 Basel
Switzerland

Tel.: +41 61 560 40 00
Fax: +41 61 560 55 55
Website: http://www.ramada.com/Ramada/control/Booking/property_info?propertyId=15756&brandInfo=RA

at the special rate of CHF 299.00 including breakfast, service and VAT.

To reserve a room, please contact the Reservations Department on +41 61 560 40 00 or fax +41 61 560 55 55 referring to the DIA Training Course on US Regulatory Affairs or click here.

IMPORTANT: To be assured of accommodation at Ramada Plaza Basel Hotel, registrants are recommended to complete their reservation by September 21, 2009.