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Seven-Part Series on Pediatric Drug Development - Part VI: Preclinical Toxicology & Safety

Sep 9 2014 11:00AM - Sep 9 2014 12:30PM | Online

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Overview 

This webinar will be broadcast in Eastern Time (ET)


Series Overview
Knowledge of new medicines for children and clinical research has increased over the past decades. A revolution has taken place in pediatric oncology, where new dosing and new combinations of anticancer drugs developed for adult cancer have made the diagnosis of child cancer no longer an automatic death sentence.

DIA is presenting a Seven-Part webinar series on Pediatric Drug Development, which will start with an overview of the challenges and historical background of pediatric drug development, then proceed to specific discussion of US and EU pediatric legislation, and, in four additional pivotal webinars, discuss technical specificities of dosing in children, particular requirements in pediatric clinical trials, the development of pediatric formulations, and the need and challenges of juvenile animal studies.

Part 6: Preclinical Toxicology & Safety Overview

Safety assessment through appropriate animal studies is a routine part of drug development. Often the preclinical toxicology department is relatively little-known in the overall drug development machinery, until a development project is stopped due to safety signals in animal studies.

Classical drug development is focused on adults. Now the use of modern drugs must take into consideration that the child’s growing organism will be exposed to these drugs. In consequence, studies in juvenile animals might be necessary to elucidate child-specific risks. This webinar will focus on the need and challenges of juvenile animal studies.


Other Webinars in this Series:

Part 1:  Overall Challenge: The Vision of Better Medicines for Children
Part 2:  Regulatory Framework
Part 3:  Regulatory Framework EU
Part 4:  Dosing in Children
Part 5:  Technical Development: Pediatric Formulations
Part 7:  Operational Challenges of Pediatric Clinical Trials 

Who Should Attend 

Scientific staff in industry working on pediatric drug development within the field of:

  • Clinical Development, Clinical Pharmacology and Formulation Development
  • Regulatory Agency Staff and Industry Regulatory Affairs
  • Clinical Investigators Involved in Pediatric Studies

Learning Objectives 

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

  • Discuss the use of animal studies as a part of pediatric drug development

Special Offers 

Buy 3 or more webinars in this series and save 15%
Buy 5 or more and save 20%
Buy the whole series and save 30%

Contact Information 

Printable Registration Form

Registration Questions and Technical Support Day of Event
Customer Service Department
Toll Free: 1.888.257.6457
Phone: +1.215.442.6100
Fax: +1.215.442.6199
CustomerService@diahome.org

Agenda Details & Event Logistics
Ellen Diegel, Event Planner
Phone +1.215.293.5810
Fax +1.215.442.6199
Ellen.Diegel@diahome.org

Technical Requirements 

Click here for minimum system requirements.

Technical Support Day of Event
Customer Service Department
Phone: +1.888.257.6457 | +1.215.442.6100
CustomerService@diahome.org

Presenter(s) 

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Continuing Education 

The Drug Information Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. The Drug Information Association designates this educational activity for up to 1.5 contact hours or .15 continuing education units (CEUs).
0286-0000-14-069-L04-P; Type of Activity: Knowledge

ACPE CREDIT REQUEST UPDATE
DIA is required by the Accreditation Council for Pharmacy Education (ACPE) to report pharmacy-requested CEUs through the CPE Monitor system. All ACPE-certified activity credit requests need to be submitted through DIA’s My Transcript within 45-days post activity. Pharmacists will need to provide their National Association of Boards of Pharmacy (NABP) e-Profile ID and date of birth (MMDD) to ensure the data is submitted to the ACPE and NABP properly. If you need to obtain your NABP e-Profile, please visit www.cpemonitor.net.

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 .2 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.

DIA’s Certificate Program Statement
This program is part of DIA’s Certificate Program and is awarded the following:
• Regulatory Affairs Certificate Program: 1 Elective Units

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

Name Credit Type Max Credits CEU
Pediatric Drug Development Part 6 ACPE 1.50 0.150
Pediatric Drug Development Part 6 IACET 1.50 0.200

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 participate in the live webinar, and complete the online credit request process through My Transcript. To access My Transcript, please go to www.diahome.org, select “Login to My DIA” and you will be prompted for your user ID and password. Select “My Transcript” (left side bar) and “Credit Request” to process your credit request. 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 on Tuesday, September 23, 2014. Continuing education credits are available to learners who participate in the live webinar. Continuing education credits are not available for participation in the archived version of the webinar.

Registration Fees 

Other Fees

Group Site
$799.00
Group Plus
$1499.00

Member

Member Government Individual
$125.00
Member Academia Individual
$175.00
Member Individual
$250.00

Non-Member

NonMember Government Individual
$125.00
NonMember Academia Individual
$175.00
NonMember Individual
$350.00
Registration Information

*SPECIAL OFFER
Buy 3 or more webinars in this series and save 15%
Buy 5 or more and save 20%
Buy the whole series and save 30%

*Order must be placed in one transaction for savings to be applied.


Group site registration is a license for ONE internet login allowing multiple viewers from one location.
Group Plus is a license for up to FIVE internet logins allowing one or more viewers at each login location.


CANCELLATIONS
No refunds will be provided in the event of a participant’s cancellation since all costs for this webinar 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.

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