FDA/IMSN Joint Global Summit on Labelling and Packaging

The United States Food and Drug Administration (FDA) and the International Medication Safety Network (IMSN) invite you to participate in a two day global summit on labelling and packaging of regulated drug products. The meeting will be held at the FDA (10903 New Hampshire Avenue, Silver Spring, MD 20993) on June 19th and 20th 2018 from 8:00 AM to 5:00 PM (Eastern US Standard Time).

Given the fact that reduction of medication errors is a main theme of the World Health Organization's (WHO) Global Patient Safety Challenge: Medication Without Harm, this meeting takes on increased importance.

This meeting will offer you the opportunity to meet with regulatory authorities around the world to discuss and collaborate towards harmonizing safe medication practices related to drug labeling and packaging. Participants will share information and answer question on best practice documents for labeling, best practices for regulatory review of naming and labelling, and pharmacovigilance efforts related to medication error.

FDA/IMSN INTERNATIONAL REGULATORS SUMMIT DRAFT AGENDA 2018

DAY 1
8:00 AM Registration
8:30 AM – 8:45 AM Opening Remarks

Welcome from the International Medication Safety Network (IMSN) and the United States Food and Drug Administration (US FDA) representatives and opening

Mike Cohen (IMSN) and Lubna Merchant (US FDA)
8:45 AM – 9:00 AM Opening remarks Janet Woodcock (US FDA)
9:00 AM – 9:30 AM Introductions of all participants All
9:30 AM – 9:45 AM Importance of this summit to the World Health Organization (WHO): Medication Without Harm Shanti Pal (WHO)
9:45 AM – 10:00 AM Purpose of summit Mike Cohen (IMSN) and Lubna Merchant (US FDA)
10:00 AM – 10:15 AM Break
10:15 AM – 11:15 AM Session one: Labeling
Discuss errors seen with expression of Strength, abbreviations and dose designations Mike Cohen- IMSN (20 minutes)
Special warning (NMB, Vinca alkaloids, KCL concentrate injection) Jan MacDonald- MHRA (20 minutes)
Format and design (prominence of drug name, strength and dosage) Irene Chan-US FDA (20 minutes)
11:15 AM – 12:30 AM Group discussion on Labeling Moderator: Danielle Harris (US FDA)

Group discussion (all regulators)

12:30 PM – 1:30 PM Lunch
1:30 PM – 2:30 PM Session Two: Packaging
Ampules (Use of a contrasting ceramic or paper background, Positioning of label on ampules) Lisiane Leal – ISMP Brazil (20 minutes)
Ready to use packaging Rabih Dabliz- UAE (20 minutes)
Methotrexate Alexios Skarlatos- EMA (20 minutes)
2:30PM – 3:15 PM Group discussion on Packaging Moderator: Claudia Manzo (US FDA)

Group discussion (all regulators)

3:15 PM – 3:30 PM Break
3:30 PM – 4:00 PM Session Three: Barcodes Greg Bylo (GS1)

Geraldine Lissalde Bonnet (GS1)

4:00 PM – 4:30 PM Group discussion on Barcode Moderator: Ilisa Bernstein (US FDA)
4:30 PM – 4:45 PM Group Picture
4:45 PM – 5:00 PM Ending day 1 and Close: Instructions for dinner/transportation/topics for next day
DAY 2
8:30 AM – 10:00 AM Session Four: Pharmacovigilance and Medication Error Reporting Programs

· Learning about systems in varied jurisdictions (US FDA slides)

· Improved collaboration

- Improved reporting
- Information Sharing
- Harmonization
Approaches to harmonization: Sonja Brajovic (US FDA)

WHO - Shanthi Pal
ANVISA - Douglas Simoes Costa Souto
US FDA - Jo Wyeth
Ghana - Dennis E. Dorbu-Amedzeame
Saudi FDA - Nasser M. Alqahtani

Moderator: Michael Hamilton (ISMP Canada)

10:00 AM – 10:15 AM Break
10:15AM – 12:30 PM Session Five: Safety Guidance

Review of current safety guidance that might exist for each of the above items

All international regulators present a 5-10 min perspective from their guidance/practices on what they have in place to address the issue identified so far

Lubna Merchant (US FDA) and Mike Cohen (IMSN)

12:30 PM – 1:30 PM Lunch- on your own
1:30 PM – 3:00 PM Session Six: Next Steps

· White paper

· Harmonized International Guidance document on drug labeling and packaging

· Follow up meeting

Lubna Merchant (US FDA) and Mike Cohen (IMSN)
3:00 PM – 3:30 PM Ending day 2 and Closing Remarks

· Invite attendee's participation and membership to IMSN

Mike Cohen (IMSN)

Your attendance and participation will be greatly appreciated as we seek to globally reduce medication errors related to labelling and packaging. Please RSVP using the form below.

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