HBA Indianapolis presents

Ask an Expert about Postmarketing Safety Reporting for Combination Products-Tips for Manufacturers

Date and time
Thursday, 05 November
11:30AM - 01:00PM EST

Event Contact
Dorothy Henckel
3. Exhibits business and industry acumen

Join our combination products consultants who have been working with companies trying to solve the issues presented by FDA’s policy on postmarketing safety reporting requirements. Not sure who or where to report adverse events related to device constituent parts? The experts can share their experiences with how the regulation will be applied for combination products and thoughts on strategy. Put a stop to your interoffice in-decision and chat with an expert.

Once registered, participants will have the opportunity to submit questions by email to the speakers. At the event this team will share experiences with postmarketing safety reporting requirements implementation, discuss pre-submitted questions, and answer general questions from the audience.

Additional Information 
To pre-submit questions email Please include the text "Ask an Expert About Safety Reporting".

11:30 – 11:40 AM Welcome and introductions
11:40 – 12:10 PM Presentation
12:10 – 12:30 PM Pre-submitted questions answered
12:30 – 1:00 PM Group Discussion and Q&A

Registration information
Event is open to: HBA Members and Nonmembers
Online registration deadline: 11/6/2020
Onsite (walk -in) registration: Is Allowed

This event is refundable, requests must be submitted in writing to by 2 November 2020

Featured speakers

Paula Burge


Registration information

The registration button at the bottom of the page will not show if online registration has closed or if the event has reached capacity. If you are a guest and the registration button is not showing, it may be that this is a member-only event. Read more about the benefits of membership or contact us about membership.

The HBA will make reasonable modifications to policies and programs to ensure that people with special needs have an equal opportunity to enjoy all of its programs. Contact us if you require special accommodations for this event.

 Price LevelRegular
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Registration: Regular Registration

 Member - Euro€9.00
 Non-Member - Euro€13.00

By registering for this event, you acknowledge that you may be photographed, videotaped and/or audio-taped during the course of the meeting and hereby give permission for your image, voice, or survey comments to be used in education, training, promotion and/or trade and communications media by the Healthcare Businesswomen's Association in any and all media throughout the world, without restriction as to frequency or duration of usage.