2014 - Vaginal Microbicides- A Wearable Intravaginal Ring (IVR) To Protect Against HIV Infection

Instructor: David Lim
Description:
This webinar is intended to discuss vaginal microbicides. FDA defines vaginal microbicides as intravaginal drug products that reduce the risk of HIV acquisition. Microbicides are applied to rectal or genital mucosa against HIV infection. Microbicides are intended to block HIV at the portal of entry, and directly at the mucosal level through delivery of high drug concentrations locally. Vaginal microbicides are designed to be self-administered products. Microbicides can be developed as vaginal formulations such as gels, creams or film, tablets, intravaginal rings (IVRs) impregnated with active product, condom impregnated with active product, etc.
This webinar will talk about regulatory requirements for vaginal microbicides to obtain FDA approvals, the products of which are intended to prevent HIV infection. In particular, the speaker will talk about IVRs. This webinar will help you increase/improve your understanding and further expedite the product development of vaginal microbicides.
FDA defines vaginal microbicides as intravaginal drug products that reduce the risk of HIV acquisition. Microbicides are applied to rectal or genital mucosa against HIV infection. Microbicides are intended to block HIV at the portal of entry, and directly at the mucosal level through delivery of high drug concentrations locally.
Why Should you Attend:
To increase and improve your awareness.
To get familiar with the relevant and applicable regulatory requirements.
To better understand and execute product design and development of vaginal microbicides in a safe and effective manner.
Objectives of the Presentation:
The objectives of the presentation are to discuss more on
Applicable laws and regulations
Definitions
Vaginal microbicides
Various formulations
Intravaginal rings
Regulatory requirements
Combination products
FDA review and approval
Speaker's suggestions for best practices in a PASS-IT manner
Who can Benefit:
Regulatory Affairs Managers, Directors and VPs
R & D Scientists, Managers, Directors and VPs
Clinical Affairs Managers, Directors and VPs
Quality Managers, Directors and VPs
Compliance Managers and Directors
Sales and Marketing Managers, Directors, and VPs
Senior and Executive Management
Product, Business Development Managers, Directors, and VPs
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