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Overview of Drug Development

Sep 8 2014 8:30AM - Sep 8 2014 4:15PM | DIA 800 Enterprise Rd Ste 200 Horsham, PA 19044

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Overview 

This course will provide an introduction to the drug development process under FDA and ICH Guidelines, including how various parts of companies fit into the overall process of pharmaceutical development. During the course, we will discuss some of the challenges to conducting scientifically sound and ethical clinical trials and the continuing evolution of regulatory requirements.

Course Level: Beginner

What You Will Learn 

  • How the pharmaceutical industry identifies new products and brings them to market
  • Contributions of key groups within the company and how they interact
  • FDA and regulation of the industry
  • Basics of filing a New Drug Application (NDA)
  • Ethical considerations in conducting clinical research
  • Concepts and functions associated with ensuring overall study quality

Who Should Attend 

This course is designed for those who are new, changing areas or roles in the pharmaceutical industry.   Also professionals who work in the area of:

  • Clinical Research
  • Project Management
  • Administrative Support
  • Quality Assurance
  • Regulatory Affairs
  • Manufacturing
  • Medical Writing
  • Business Support

Learning Objectives 

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

  • Recognize the process of discovering and developing new pharmaceutical products
  • Describe the activities associated with conducting clinical research and reporting the results and responsibilities of various departments in accomplishing these activities
  • Discuss institutional review, informed consent, and financial disclosure
  • Explain the concepts and functions associated with ensuring overall quality of studies
  • Describe the organization of the FDA, their authority, and interactions with sponsor companies

Special Offers 

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

Hotel & Travel 

Training Course Location
DIA 
800 Enterprise Road, Suite 101
Horsham, PA 19044

Hotel Information
Staybridge Suites Philadelphia- Montgomeryville
119 Garden Golf Blvd    
North Wales ,  PA   19454
Phone +1-215-393-8899
Fax +1-215-393-8898

A limited number of rooms are available at the reduced rate shown below (DIA is guaranteed until August 24, 2014 or until room block is filled). Attendees should make airline and room reservations as soon as possible.  When making reservations, mention the DIA training course.

Standard Room Rate  $109
Click here for more hotel information

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 Details and Event Logistics
Colleen Buckley, Event Planner
Phone +1.215.442.6108
Fax +1.215.442.6199
Colleen.Buckley@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 6.5 professional development units (PDUs). PMI#: 2166-000131

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 offer .7 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:
• Clinical Research Certificate Program: 4 Core Units
• Regulatory Affairs Certificate Program: 4 Elective Units

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

Name Credit Type Max Credits CEU
Overview of Drug Development IACET 6.50 0.700
Overview of Drug Development PMI 6.50 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
$470.00
Member Government
$470.00
Member Standard
$840.00
Member Standard (As of 08/19/2014)
$940.00

Non-Member

Charitable Nonprofit/Academia Nonmember
$695.00
NonMember Government
$695.00
NonMember Standard
$1165.00
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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