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Art of Writing a Clinical Overview

Sep 9 2013 9:00AM - Sep 9 2013 5:00PM | DIA 800 Enterprise Rd Ste 200, Horsham, PA 19044-3509 USA

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Overview 

This course provides an in-depth analysis of the preparation of a Clinical Overview for pharmaceutical products (drugs and biologics) in accordance with ICH guidelines concerning development of Module 2.5 of a Common Technical Document (CTD).  Participants will gain the necessary knowledge and insights for writing a document that provides a critical assessment of the evidence for the benefit and risks of the investigational product in the target indication.

What You Will Learn 

  • Objectives, structure, and format of the Clinical Overview, with attention given to developing a document suitable for multi-region submissions
  • Inclusion and presentation of clinical and nonclinical data, with emphasis on how to effectively use the other technical summaries within the CTD
  • How to frame the different sections of the Clinical Overview to best communicate the product’s unique attributes

Who Should Attend 

  • Clinical Research and Development
  • Medical Writing
  • Regulatory Affairs involved in the preparation or review of Module 2.5 of a CTD

Learning Objectives 

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

  • Communicate the role of a Clinical Overview (Module 2.5) in a CTD
  • Describe the structure and format of a Clinical Overview in accordance with ICH guidelines
  • Develop strategies regarding the placement and presentation of information in different sections of the Clinical Overview
  • Explain how to effectively cross-reference to other components of the CTD
  • Develop a submission-ready Clinical Overview that successfully communicates all available information concerning the benefits and risks of an investigational product
  • Recognize how to modify the Clinical Overview for different submission types

Special Offers 

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

Hotel & Travel 

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

Hotel Information
Homewood Suites
2650 Kelly Road
Warrington, PA 18976
Phone +1-215-343-1300
Fax +215-343-1335

A limited number of rooms are available at the reduced rate shown below (DIA is guaranteed until August 25, 2013, 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
$119
Click here for more hotel information

Contact Information 

Registration Questions
Marilyn Ginsberg, Customer Service Associate
Phone +1.215.442.6135
Fax +1-215.442.6199
Marilyn.Ginsberg@diahome.org

Agenda and Event Details
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 

Drug Information Association has been accredited as an Authorized Provider by the International Association for Continuing Education and Training (IACET), 1760 Old Meadow Road, Suite 500, McLean, VA 22102.

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
Art of Writing a Clinical Overview IACET 6.75 0.700

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 08/20/2013)
$940.00

Non-Member

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

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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