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European Regulatory Affairs: Keeping Your Finger on the Pulse of Marketing Authorizations

Aug 18 2014 8:30AM - Aug 19 2014 5:15PM | Sheraton Boston Hotel 39 Dalton Street, Boston, MA 02119 USA

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Overview 

This training course provides description and discussion of the complete spectrum of necessary regulatory procedures: marketing authorization registration procedures, variation procedures, renewal procedures and more. Expert instructors use practical examples and experiences to illustrate procedures. The course focuses on Europe but also reviews regulations in other regions including the US and Japan.

Course Level: Intermediate

What You Will Learn 

  • Drug Regulations
  • Role of Regulatory Affairs in Drug Development / Approval / Marketing
  • Registration Dossier
  • Regulatory Strategy
  • Variations: The Role of Regulatory Affairs after Marketing Authorization
  • Transparency in Drug Regulatory Affairs

Who Should Attend 

This course provides the knowledge and tools for experts and managers from the regulatory agencies and pharmaceutical industry working in the areas of:

  • Regulatory Affairs
  • Clinical drug development
  • Preclinical drug development
  • Pharmaceutical development
  • Manufacturing
  • Drug quality control
  • Quality assurance and compliance
  • Regulatory writing
  • Drug import /export

Learning Objectives 

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

  • Define the drug legislation and regulation with a focus on the EU
  • Demonstrate successful knowledge of the Internet to locate relevant documents
  • Identify the key functions of regulatory affairs during the different phases of a drug life cycle
  • Formulate successful regulatory strategies and apply it to the product concerned

Special Offers 

Group Discounts Available! Register 3 and Get the 4th FREE!

Hotel & Travel 

Hotel and Course Location / Information

Sheraton Boston Hotel
A limited number of rooms are available at the reduced rate shown below (DIA rate is guaranteed until August 04, 2014, or until room block is filled). Attendees must make their own hotel reservations.

Standard Room Rate $199
Hotel Address: 39 Dalton Street • Boston, MA 02199 • United States
Click here for Reservations

The most convenient airport is Logan Airport and attendees should make both airline and hotel reservations as early as possible.

Contact Information 

Registration Questions
Toll Free 1.888.257.6457
Phone +1.215.6100
Fax +1.215.442.6199
Monday-Friday 8:30AM-8:00PM ET
CustomerService@diahome.org

Agenda and Event Logistics
Susan Berkelbach, Event Planner
Phone +1.215.442.6183
Fax +1.215.442.6199
Susan.Berkelbach@diahome.org

Faculty 

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Continuing Education 

Drug Information Association has been accredited as an Authorized Provider by the International Association for Continuing Education and Training (IACET).

As an IACET Authorized Provider, Drug Information Association offers CEUs for its programs that qualify under the ANSI/IACET Standard. Drug Information Association is authorized by IACET to offer 1.5 CEUs for this program. Participants must attend the entire program in order to be able to receive an IACET statement of credit. No partial credit will be awarded.

This program is part of DIA’s Certificate Program and is awarded the following:
• Regulatory Affairs Certificate Program: 6 Core Units

For more information go to www.diahome.org/certificateprograms

Name Credit Type Max Credits CEU
European Regulatory Affairs: Keeping Your Finger o IACET 14.50 1.500

Disclosure Policy:

It is DIA policy that anyone in a position to control the content of a continuing education activity must disclose to the program audience (1) any real or apparent conflict(s) of interest related to the content of their presentation and/or the educational activity, and (2) discussions of unlabeled or unapproved uses of drugs or medical devices. Disclosure statements will be included in the course materials.

Statement of Credit:

If you would like to receive a statement of credit, you must attend the activity, sign-in at the DIA registration desk each day of the activity, and complete the online credit request process through My Transcript at www.diahome.org . Participants will be able to download a statement of credit upon successful submission of the credit request. My Transcript will be available for credit requests two weeks after the last day of the activity.
Please note: If you do not sign-in, you will not receive CE credit as partial credit will not be awarded.

To view DIA’s Grievance Policy, please visit the CE page on the DIA website at www.diahome.org/CE

Registration Fees 

Member

Charitable Nonprofit/Academia Member
$810.00
Member Government
$810.00
Member Standard
$1375.00
Member Standard (As of 07/29/2014)
$1475.00

Non-Member

Charitable Nonprofit/Academia Nonmember
$1035.00
NonMember Government
$1035.00
NonMember Standard
$1700.00
Group Discounts

 Printable Registration Form

Register 3 individuals from the same company and receive complimentary registration for a 4th! All 4 individuals must register and prepay at the same time – no exceptions. DIA will apply the value of the lowest applicable fee to this complimentary registration; it does NOT include fees for optional events or DIA membership. You may substitute group participants of the same membership status at any time; however, administrative fees may be incurred. Group registration is not available online and does not apply to the already discounted fees for government or charitable nonprofit/academia.

To take advantage of this offer, please make a copy of this registration form for EACH of the four registrants from your company. Include the names of all four group registrants on each of the forms and return them together to DIA.

Register Online

Cancellations: Cancellations must be received two weeks prior to the first day of the course. A $200 administrative charge will be deducted from the original registration fee. Cancellations must be in writing and received in the DIA office according to the timeline above. There will be no refund if cancellation is received within two weeks from the first day of the course. Registrants are responsible for cancelling their own hotel and travel reservations. Registrants who do not cancel prior to the course and do not attend will be responsible for the full registration fee. DIA reserves the right to alter the venue, if necessary. If an event is cancelled, DIA is not responsible for airfare, hotel or other costs incurred by registrants.

Transfers: You may transfer your registration to a colleague at any time but membership is not transferable. Please notify the DIA North American office of such transfers in writing as soon as possible. Substitute registrants will be responsible for the nonmember fee, if applicable.

Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.

Participants with Disabilities:
Reasonable accommodations will be made available to persons with disabilities who attend an educational activity. Contact the DIA office in writing at least 15 days prior to event to indicate your needs.

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