Extractables and Leachables for Parenteral Applications - Korea

Incheon, South Korea
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When making parenteral drug products, pharmaceutical companies are faced with the regulatory requirements to further investigate the materials that will be in contact with the drug product either during manufacturing, intermediate storage, storage in its final packaging, or during the delivery of the drug to the patient. While historically, the potential safety issues were the main driver in these kinds of investigations, recently, quality issues – i.e. for biopharmaceuticals – have become an additional concern.

This training course will look at Extractables and Leachables (E/L) from many different angles:

  • Regulatory Requirements and Guidelines eg. USP <1663> (Extractables Testing), USP <1664> (Leachables Testing), USP <661> (Plastic Packaging Systems), USP<665> versus BPOG (for Single Uses Systems)
  • Material & Polymer Science
  • Mechanisms of Leaching and Material-Drug Product Interaction
  • Analytical E/L Methodologies
  • E/L Study Design for Different Packaging Systems
  • Large Volume Parenterals
  • Lyo Applications

Several interesting case studies on the above topics will also be presented.

  1. Identify which regulations are to be followed and what is applicable
  2. Recognize the impact of the physicochemical properties of a polymers and their impact on the leachable mechanism
  3. Identify which analytical techniques are necessary in a comprehensive E/L program and what they should accomplish
  4. Assess the results of an E/L program from a safety perspective
  5. Design an E/L study that is compliant with the regulatory requirements, by choosing the right set of testing conditions

Standard Pricing

Standard Member Price

USD $599

GovernmentMember Only

USD $599

Health AuthorityMember Only

USD $599

AcademicMember Only

USD $599

Non-Member

USD $599

See Qualifying Criteria for Member Types.

Day 1

Training courses run from 8:30 to 16:00 each day, unless otherwise noted. An agenda will be provided on the first day of the training course.

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

A block of rooms have been reserved for meeting participants. The rate is $170000 KRW/night.

Reservations must be secured by Saturday, September 14, 2019. After this date, reservations can be made on a space and rate available basis only.

Book your room at the discounted group rate here:
https://www.marriott.com/event-reservations/reservation-link.mi?id=1562922487934&key=GRP&app=resvlink

Individual Cancellation

Please be aware that obtaining and cancelling hotel reservations is the responsibility of the registrant. Individuals will be responsible for payment of their own cancellation fees. The cancellation policy is 3 days in advance of arrival unless otherwise specified on your reservation information.


Please visit the hotel’s website for more information.

How to Get Here
By Air

INCHEON INTERNATIONAL AIRPORT (ICN)

Hotel direction: 15.5 miles W
Airport shuttle service, reservation required, fee: 95000 KRW (one way) 24 Hours, 7 days a week
Shuttle Phone: +82 32 8351000

Estimated taxi fare: 40,000 KRW (one way)
Bus service, fee: 7,000 KRW (one way)

GIMPO INTERNATIONAL AIRPORT (GMP)

Hotel direction: 21.7 miles NE
Airport shuttle service, reservation required, fee: 95000 KRW (one way) 24 Hours, 7 days a week
Shuttle Phone: +82 32 8351000

Estimated taxi fare: 40,000 KRW (one way)

By Car

CAR RENTALS

Lotte Rent-A-Car 
145 Chungneung-daero
Incheon, 21930
Phone: "+82 032 882; ext= 8001"

Hertz 
Incheon Inter AP Passenger Terminal
Incheon,
Phone: +82 32-743-8000