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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.

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-46654530958 by 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. 

Meeting Materials:

• ADEPT5 Final Agenda (PDF - 80 KB)

Slides:

• PEDSnet: A National Pediatric Learning Health System, Bailey (PDF)

• FDA Pediatric Pharmacovigilance: Deferasirox (Exjade® / Jadenu®), S. Bird (PDF)

• Pediatric pharmacovigilance and current data sources: The use of Sentinel in Pediatric Safety, J. Brown (PDF)

• Advancing the Development of Pediatric Therapeutics:  Advancing Pediatric Pharmacovigilance, Hausman (PDF)

• Advancing Pediatric Pharmacovigilance (ADEPT 5), H. Francis (PDF)

• The Benefits of Linked Data for Patient Safety, R. Kher (PDF)

• Pediatric Pharmacovigilance for Drug and Biological Products at the Food and Drug Administration, C. Kortepeter (PDF)

• Using Machine Learning to Identify Individual Case Safety Reports in Social-Digital Media, S. Perera (PDF)

• Drug Safety Research in Canada, Platt (PDF)

• Investigation of Artificial Intelligence in the Interpretation of Adverse Event Reports, S. Proestel (PDF)

• Background of Advancing the Development of Pediatric Therapeutics (ADEPT) Workshops, K. Quinto (PDF)

• Opportunities and challenges in using observational health data for pediatric pharmacovigilance, P. Ryan (PDF)

• Mobile technology, social media and paediatric signal detection, P. Tregunno (PDF)

• Lessons From Health Security Intelligence, J. Wilson (PDF)

Webcast:

• Part 1: https://collaboration.fda.gov/p3qcla7ecyy/
• Part 2: https://collaboration.fda.gov/p3vb8sq5zc5/
• Part 3: https://collaboration.fda.gov/p7u5wfx2uzb/

More Information:  Contact Denise Pica-Branco, (301)796-1732; e-mail [email protected] or Meshaun Payne, (301)796-6668; e-mail [email protected]; or FAX (301)796-9858.