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Global Regulatory Strategy and Drug Development in Asia-Pacific, Latin America and Other Emerging Markets

Sep 15 2014 8:30AM - Sep 16 2014 4:15PM | Hilton Washington DC/Rockville Hotel & Executive Meeting Ctr. 1750 Rockville Pike, Rockville, MD 20852 USA

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Overview 

The course will provide to participants practical, actionable information on the nature and development of global regulatory strategies for drug development, with a focus on markets located outside the United States and Europe. Descriptions of the local regulatory environments and requirements for drug development will be enhanced by case examples and by practical experiences in Asia Pacific, Latin America, Africa and other Emerging Markets.

Course Level: Intermediate

What You Will Learn 

  • Global regulatory strategy considerations and construction
  • Unique challenges outside the United States and the European Union
  • Regulatory environments and communications with regulators in diverse world markets

 

Who Should Attend 

Pharmaceutical professionals with an interest in global regulatory requirements in the areas of:

  • Regulatory Affairs 
  • Clinical Development
  • Research and Development
  • Medical
  • Comercialization and Market Access

Learning Objectives 

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

  • Discuss building global drug regulatory strategy including how to develop one in the context of global project teams
  • Compare the unique and diverse challenges of working with different regulatory environments, regulators, and cultures
  • Determine optimal ways of communicating effectively with drug regulatory authorities located outside the United States and Europe
  • List the fundamental regulatory requirements for drug development and approval in Japan, China, other significant Asia Pacific markets, Latin America and other emerging markets

Special Offers 

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

Hotel & Travel 

Hotel and Course Location / Information

Hilton Washington DC/Rockville Hotel & Executive Meeting Center
A limited number of rooms are available at the reduced rate shown below (DIA rate is guaranteed until August 18, 2014, or until room block is filled). Attendees must make their own hotel reservations. When calling the hotel please indicate you are attending a DIA training course under a Group reservation.

Standard Room Rate $219

Hotel Address: 1750 Rockville Pike
Rockville,  Maryland,  20852-1699, 
TEL: 1-301-468-1100 FAX: 1-301-468-0308
Click here for reservations

The most convenient airport is Washington Dulles 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 1.3 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.

CERTIFICATE PROGRAMS

These programs are part of DIA’s Certificate Program and are awarded the following:
• Clinical Safety and Pharmacovigilance Certificate Program: 4 Elective Units each
• Regulatory Affairs Certificate Program: 8 Elective Units each

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

Name Credit Type Max Credits CEU
Global Regulatory Strategy and Drug Development in IACET 13.00 1.300

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, 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.

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

Registration Fees 

Member

Charitable Nonprofit/Academia Member
$810.00
Member Government
$810.00
Member Standard
$1475.00

Non-Member

NonMember Government
$1035.00
Charitable Nonprofit/Academia Nonmember
$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

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.

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