News & Events > Advancing the Development of Pediatric Therapeutics 5 (ADEPT5): Advancing Pediatric Pharmacovigilance Public Workshop

News & Events > Advancing the Development of Pediatric Therapeutics 5 (ADEPT5): Advancing Pediatric Pharmacovigilance Public Workshop





Public Workshop: Advancing the Development of Pediatric Therapeutics 5 (ADEPT5):
Advancing Pediatric Pharmacovigilance

FDA’s Division of Pediatric and Maternal Health in CDER, is announcing a 1-day public workshop, “Advancing the Development of Pediatric Therapeutics 5 (ADEPT5): Advancing Pediatric Pharmacovigilance” to provide a forum to gather information on the latest developments in pediatric pharmacovigilance from the perspective of a number of stakeholders and to expand the conversation to include the utility and challenges of emerging pharmacovigilance tools, including specific challenges associated with pediatric data tools.

The public workshop will be held on September 14, 2018 from 8:00 am to 5:00 pm EDT at the FDA White Oak Campus in Silver Spring, MD.

Registration is required by September 6, 2018

FDA’s Division of Pediatric and Maternal Health in CDER, is announcing a 1-day public workshop, “Advancing the Development of Pediatric Therapeutics 5 (ADEPT5):  Advancing Pediatric Pharmacovigilance”.  The purpose of this 1-day workshop is to provide a forum to gather information on the latest developments in pediatric pharmacovigilance from the perspective of a number of stakeholders and to expand the conversation to include the utility and challenges of emerging pharmacovigilance tools, including specific challenges associated with pediatric data tools. 

The public workshop will be held on:

Date:               September 14, 2018

Time:               8:00 am to 5:00 pm

Location:  The public workshop will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31, the Great Room (Rm. 1503A), Silver Spring, MD 20993-0002.  Entrance for the public workshop participants (non-FDA employees) is through Bldg. 1 where routine security check procedures will be performed.  For parking and security information, please refer to https://www.fda.gov/aboutfda/workingatfda/buildingsandfacilities/whiteoakcampusinformation/ucm241740.htm. 

Registration:  Persons interested in attending this public workshop must register online at https://www.eventbrite.com/e/advancing-thedevelopment-of-pediatric-therapeutics-5-adept5-tickets-46654530958by Thursday, September 6, 2018, midnight Eastern Time. Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone. Onsite registration will not be available. Registration for onsite participation or via webcast is free and based on space availability, with priority given to early registrants. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. Registrants will receive confirmation when they have been accepted. 

More Information:  Contact Denise Pica-Branco, (301)796-1732; e-mail denise.picabranco@fda.hhs.gov or Meshaun Payne, (301)796-6668; e-mail meshaun.payne@fda.hhs.gov; or FAX (301)796-9858.