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Art of Writing a Clinical Overview

Sep 9 2014 11:30AM - Sep 11 2014 1:30PM | Online

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Overview 

This online training will be broadcast in Eastern Time (ET)


This basic online training 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).

Course Level: Beginner

Featured Topics 

  • 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
  • Insight is provided on how to prepare a document that successfully communicates the benefits and risks of the investigational product
  • How to frame the different sections of the Clinical Overview to best communicate the product’s unique attributes
  • Identify how to develop the Clinical Overview for other types of submissions

Who Should Attend 

  • Clinical research and development professionals
  • Medical writers
  • Regulatory affairs personnel 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 

Register More than One Group Site and Save 15%!

Contact Information 

Registration Questions and
Technical Support Day of Event

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
Colleen Buckley, Event Planner
Phone +1.215.442.6108
Fax +1.215.442.6199
Colleen.Buckley@diahome.org

Technical Requirements 

Click here for minimum system requirements.

Technical Support Day of Event
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

Faculty 

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Continuing Education 

P>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 .6 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 each
• Regulatory Affairs Certificate Program: 4 Elective Units each

For more information go to www.diahome.org/certificateprograms
Name Credit Type Max Credits CEU
Art of Writing a Clinical Overview IACET 6.00 0.600

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:

Continuing education credits are available to learners who participate in the live online training course. To request credit, complete the on-line 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.

Continuing education credits are available to learners who participate in the live online training course. Continuing education credits are not available for participation in the archived version of the online training course.

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

Agenda  

Day 1 Tuesday, Sep 09, 2014

  • 11:30AM - 1:30PM

    Part 1 - Introduction to Clinical Overview and the Product Development Rationale

Day 2 Wednesday, Sep 10, 2014

  • 11:30AM - 1:30PM

    Part 2 - Strategies in Preparation of Sections 2 to 5 of Clinical Overview

Day 3 Thursday, Sep 11, 2014

  • 11:30AM - 1:30PM

    Part 3 - Preparing the Benefit - Risk Assessment and Best Practices for Clinical Overview Construction

Registration Fees 

Other Fees

Group Site
$1750.00

Member

Charitable Nonprofit/Academia Member Individual
$350.00
Member Government Individual
$350.00
Member Standard Individual
$695.00

Non-Member

Charitable Nonprofit/Academia Nonmember Individual
$435.00
NonMember Government Individual
$435.00
NonMember Standard Individual
$785.00
Group Discounts

GROUP SITE:
Group Site is a license for one internet and audio log-in, allowing multiple viewers at one physical location. All other fees are for one log-in allowing one viewer.

*Receive a 15% discount on the entire purchase when you register for more than one group site at the same time. Valid only when group sites are purchased online for this training series.

This online training offering is sold as one complete series and cannot be purchased in parts.


Cancellation Policy: No refunds will be provided in the event of a participant’s cancellation since all costs for this online training course have been prepaid by DIA. DIA reserves the right to modify or cancel programs and/or substitute presenters or panelists. DIA is not responsible for failure to deliver programs due to circumstances beyond its control.
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.

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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