Ophthalmic Preparations

Opthalmic Workshop
October 21, 2013 - October 22, 2013
REGISTER

Overview

Overview: 

USP is currently reviewing General Chapter <771> Ophthalmic Ointments to include all dosage forms that can be applied into the eye. The new version of Chapter <771> Ophthalmic Preparations will also include quality tests (sterility, bacterial endotoxins, osmolarity, etc.) and dissolution/drug release tests that are applicable to all these dosage forms.

The workshop will present information on the routes of administration into the eye and types of dosage forms that can be applied through these routes for human and veterinary uses, quality attributes that are critical for ophthalmic dosage forms (such as microbiological requirements), bacterial endotoxins, particulate matter, leachables and extractables, etc. Also, the dissolution and drug release tests used to evaluate the in vitro performance of this type of product will be discussed.

Topics: 
  • Overview of the revision being made to USP General Chapter <771> Ophthalmic Preparations
  • Routes of administration into the eye
  • Dosage forms that can be applied into the eye for both human and veterinary uses
  • Formulation approaches to overcome barriers in the eye
  • Microbiological requirements (sterility, antimicrobial effectiveness, bacterial endotoxins)
  • Critical quality attributes of ophthalmic dosage forms (particulate matter, leachables and extractables)
  • Stability requirements
  • Dissolution/drug release from modified dosage forms
Who Should Participate: 

This workshop is intended for all stakeholders (industry, regulators, and associations). This includes professionals working in or with:

  • Microbiological laboratories
  • Quality assurance/quality control
  • Research and development
  • Contract research organizations
  • Regulatory affairs
  • Veterinary products
  • Formulation development

Agenda

application/msword iconAgenda

Registration Information

Regular Price Information: 
  • Academia/Association/Government Participant─$495
  • Industry Participant─$695
  • FDA Rate─$150
Early Discount Information: 
  • Academia/Association/Government Participant─$395
  • Industry Participant─$595
  • FDA Rate─$150
Early Registration Deadline: 
September 20, 2013
Other Registration Information: 

Registration fee includes full two-day program; meeting materials; continental breakfast and lunch each day and a networking reception. Contact conferences@usp.org for details.

USP Headquarters
12601 Twinbrook Parkway
Rockville, MD 20878
Estados Unidos
Phone: +1-301-816-8136
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Local Area Information

Nearby Hotels

Hilton Washington DC/Rockville

Hotel and Executive Meeting Center
1750 Rockville Pike
Rockville, MD 20852
Main Phone: +1-301-468-1100

USP Corporate Rate: $191* per night (+ taxes)
Rate includes free Internet.
Location: The Hilton Washington DC/Rockville is a 10-minute walk from USP Headquarters and is accessible by the Twinbrook Metro Station.

Bethesda North Marriott Hotel and Conference Center

5701 Marinelli Road
North Bethesda, MD 20852
Main Phone: +1-301-822-9200

USP Corporate Rate: $191* per night (+ taxes)
Rate includes free Internet.
Location: The Bethesda North Marriott Hotel is accessible by the White Flint Metro Station.

*Keep in mind, the property will do its best to honor USP's corporate rate; however, this is not always guaranteed. Corporate rates are honored depending on hotel availability, holidays, in-house meetings, etc.