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New Drug Product Development and Life Cycle Management

Aug 18 2014 8:30AM - Aug 19 2014 12:45PM | Sheraton Boston Hotel 39 Dalton Street, Boston, MA 02119 USA

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Overview 

Drug development is an incredibly complex and risky endeavor, one that even experienced organizations will fail at more often than they succeed.  This course will help you understand how companies structure their efforts and utilize their resources to improve the odds of successful development, and minimize the risks associated with shepherding a new drug candidate through the development process.

At the end of this course, you will be able to explain the phases, major work streams, key players and interrelationships necessary to develop new drugs and to expand the life cycle of in-line products. Interactive exercises will take you through the many decisions faced by an organization as they progress a new drug candidate through development and beyond.

Course Level: Beginner

What You Will Learn 

  • Drug development process
  • Candidate identification/preclinical testing
  • Phases 1
  • Phase 2
  • Phase 3 and regulatory review
  • Phase 4 and life cycle management

Who Should Attend 

Professionals who wish to broaden their understanding of drug development in the pharmaceutical or biotechnology industry. This course should be of particular interest to those people who are moving from primarily functional positions into team membership roles or who are transitioning from other industries or from academia.

Learning Objectives 

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

  • Explain how a desired drug product label dictates the components of the drug development plan
  • Identify the five major work streams that must be completed in any drug development program and describe their interactions
  • Describe the key functional area players and when they contribute to the six phases of drug development
  • Discuss the life cycle management process and how product line extensions are developed
  • Recognize the major differences between drug, biologic, and drug device development
  • List where to find additional information on biologic and drug device development

Special Offers 

Purchase this course and Project Risk Management together and receive 20% off at registration!

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 

The Drug Information Association has been reviewed and approved as a provider of project management training by the Project Management Institute (PMI). This program offers a maximum of 11.25 professional development units (PDUs). PMI#: 2166-000133

The PMI Registered Education Provider logo is a registered mark of the Project Management Institute, Inc.

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 offer1.1 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:
• Project Management Certificate Program: 8 Core Units

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

Name Credit Type Max Credits CEU
New Drug Product Development and Life Cycle Manage IACET 11.25 1.100
New Drug Product Development and Life Cycle Manage PMI 11.25 0.000

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.
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
$625.00
Member Government
$625.00
Member Standard
$1135.00

Non-Member

Charitable Nonprofit/Academia Nonmember
$715.00
NonMember Government
$715.00
NonMember Standard
$1360.00
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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