Vaginal Microbicides- A Wearable Intravaginal Ring To Protect Against HIV Infection

Duration: 60 Minutes
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.
HIV infection
Instructor: David Lim
Product ID: 500439

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
Live Session - How it works
  • Username and Password will be sent to you 24 hours prior to the webinar
  • Presentation handouts in pdf formate will be mailed to you
  • Login to the session using the username and password provided to you
  • Get answer to your queries through interactive Q&A sessions via chat
  • Please let us know your thoughts and views at the end of webinar, your valuable feedback will help us improve
  • Get certification of attendance.
Recorded Session - How it works
  • A link will be provided to you upon purchase of the recorded session
  • Please click on the link to access the session
  • Presentation handouts in pdf formate will be mailed to you
  • Get certification of attendance.
$375
Recorded Session for one participant
Get life time access with download option!
Book this course
Pay Now
  $500.00 Training CD
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
  $600.00 Training USB Flash Drive
Free shipment within 4 Working Days of placing the order. Get life time access for unlimited participants.
For multiple location please contact our customer care team +1-510-857-5896.
How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Dr. David Lim is President and Principal of Regulatory Doctor. Regulatory Doctor provides Practical, Actionable, and Sustainable Solutions in an Integrated, Thorough ("PASS-IT") manner.

Dr. Lim obtained his Ph.D. in biological sciences at the University of Missouri-Columbia and published his thesis research in the prestigious journal "Science." Since then, Dr. Lim has held various positions at Duke, Caltech, US National Laboratories, Intrexon Corporation, Terumo, US FDA/CDRH, and EraGen Biosciences, Inc., A Luminex Company. In 2009, Dr. Lim served as a panel member during the FDA’s Transparency Public Meeting. Prior to founding his own consulting firm (www.RegulatoryDoctor.com), Dr. Lim was Senior Vice President of Scientific and Regulatory Affairs at Aquavit Pharmaceuticals, Inc. in New York. Dr. Lim as Regulatory Doctor provides practical, actionable and strategic solutions integrated with emotional intelligence (EQ) skills for all aspects of global regulatory, quality, clinical and compliance matters.

Over the years, Dr. Lim has analyzed thousands of FDA warning letters including thousands of MDRs. Dr. Lim has also attended more than 50 FDA advisory panel Meetings and analyzed the subject matters and decision-making processes. Dr. Lim is familiar with hundreds of medical products (medical devices including IVD products, biologics, drugs and combination products). Dr. Lim is a certified professional for regulatory affairs (RAC) and also is a certified quality auditor (CQA) by the American Society for Quality (ASQ). Dr. Lim also is a regulatory coach, mentor, consultant and public speaker for global matters pertaining to regulatory affairs, regulatory compliance, quality and clinical affairs. Dr. Lim has been actively engaged in identifying and addressing regulatory hurdles and submission issues including, but not limited to, patient-safety signals and concerns. Dr. Lim co-authored the Regulatory Affairs Professional Society (RAPS)'s online class materials for EU medical device regulations.
View More