On April 18-19, 2018, PQRI will host a public Workshop: PQRI PODP Extractables & Leachables (E&L) Workshop. This is the official rollout and first full Workshop to explain and discuss the PQRI Safety Thresholds and Best Demonstrated Practices for Parenteral and Ophthalmic Drug Products (PODP).
Hear from the Experts who developed the E&L Recommendations, including representatives from Industry, MHRA, Health Canada and FDA.
A two-day event focused on the findings and outcomes of the PQRI PODP E&L work. You will learn:
- How thresholds for parenteral products were derived
- Applicability of the thresholds to Small Volume Parenterals, Large Volume Parenterals, and Pre Filled Syringes
- Principles and concepts behind best demonstrated practices
- Extractable considerations for ophthalmic products
- Safety and quality concerns for biologics
Attendees will learn about justifying study designs for extractable studies and assessing leachable safety.
Registration is now open, click here to register.
Presentations will be available after April 1, 2018 for registered attendees only. (Registered attendees will receive a password from the Workshop organizers.)
PQRI will host a Networking Reception on Wednesday, April 18, 2018 from 5:30 – 7:30 PM at the Hilton Washington DC/Rockville Hotel and Executive Meeting Center. See address and information below.
Registration fee does not include hotel rooms. Please contact the hotel directly to make reservations. We suggest the below listed hotels:
Hilton Washington DC/Rockville Hotel and Executive Meeting Center
1750 Rockville Pike
Rockville, MD 20852
Use Corporate Account Code: 2663246
This hotel is within walking distance of USP (0.5 miles) and is next to the Twinbrook Metro Station.
Even Hotels Rockville
1775 Rockville Pike
Rockville, MD 20852
This hotel is approximately one mile from the USP Campus, across the street from Hilton.
Bethesda North Marriott Hotel and Conference Center
5701 Marinelli Road
North Bethesda, MD 20852
+1 301 822-9200 or +1 877-212-5752
Use Corporate /promotional Code: UFA
This hotel is located adjacent to White Flint Metrorail Station on the Red Line. USP is one stop away at Twinbrook Metro Station. (Walking Directions to USP from Twinbrook Metro.) Taxi service is also available. One-way taxi fare to the USP campus is approximately $10.
**Please note that we do not have a block of rooms reserved so we suggest that you make your reservation early if you wish to secure lodging at these hotel.**
Please contact the PQRI Secretariat if you have any questions at +1(202) 230-5199 or PQRISecretariat@pqri.org.