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Implementation of the FDASIA Patient Provisions

Mar 5 2014 11:00AM - Mar 5 2014 12:30PM | Online

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Overview 

This webinar will be broadcast in Eastern Time (ET)


FDA has a long history of including the patient perspective through the FDA Patient Representative Program, where patients have been mainly included on Advisory Committees. The Food and Drug Administration Safety and Innovation Act (FDASIA) included multiple provisions to increase the inclusion of the patient perspective in FDA's decision-making.  This webinar will provide an overview of these new programs, and get an update on their implementation. Both Section 1137 of FDASIA and the Patient Focused Drug Development commitment in PDUFA V have moved to include the patient perspective earlier in regulatory discussions with industry. The session will provide a brief historical introduction, followed by a high-level overview of these new patient provisions. The FDA staff responsible for implementing these provisions will provide a detailed update on their progress and share their vision for the evolving role of patient advocacy in regulatory decision-making. A patient advocate will provide their views on FDA's progress in implementing these provisions, as well as the role that the patient advocacy community can play as partners in these initiatives.

Featured Topics 

  • FDASIA
  • Patient Representatives
  • Patient Focused Drug Development

Who Should Attend 

  • Industry patient engagement professionals
  • Patient advocates
  • Regulators interested in enhancing patient input

Learning Objectives 

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

  • Discuss the FDASIA enhancements to FDA’s patient advocacy programs 
  • Describe FDA’s progress and vision in implementing the various patient provisions
  • Identify opportunities for external stakeholders to engage with FDA’s patient advocacy programs

Contact Information 

Printable Registration Form

Registration Questions and Technical Support Day of Event
Toll Free 1.888.257.6457
Phone +1.215.442.6100
Fax +1.215.442.6199
Monday-Friday 8:30AM-8:00PM ET
CustomerService@diahome.org

Agenda Details
Jessica McGrory
In-Company Training Manager
Phone +1.215.442.6182
Fax +1.215.442.6199
Jessica.McGrory@diahome.org

Event Logistics
Benjamin Zaitz, Event Planner
Phone +1.215.293.5803
Fax +1.215.442.6199
Benjamin.Zaitz@diahome.org

Technical Requirements 

Click here for minimum system requirements.

Technical Support Day of Event
Toll Free 1.888.257.6457
Phone +1.215.442.6100
Fax +1.215.442.6199
Monday-Friday 8:30AM-8:00PM ET
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).
0286-0000-14-062-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
Implementation of the FDASIA Patient Provisions ACPE 1.50 0.150
Implementation of the FDASIA Patient Provisions 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 Thursday, March 19, 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
Charitable Nonprofit/Academia Member Individual
$175.00
Member Individual
$250.00

Non-Member

NonMember Government Individual
$125.00
Charitable Nonprofit/Academia Nonmember Individual
$175.00
NonMember Individual
$350.00
Group Discounts

  • 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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