Pharmacovigilance and Risk Management Conference
June 9 & 10, 2020
This event is FREE to attend
Virtual Online Attendance Only
This training is designed to provide participants with a foundation in regulations, FDA guidances, and risk-based principles aimed at ensuring safety of marketed drug and biological products. The training will include regulatory approaches to prevent medication errors, and the application of regulations and guidances to design labels and labeling to prevent medication errors. FDA will also discuss advances in approaches, tools, and technologies for medication error prevention, pharmacovigilance, and risk management.
Featured FDA Speakers:
Gerald Dal Pan, MD, MHS
Claudia Manzo, PharmD
Lubna Merchant, PharmD
Judith Zander, MD
- Best Practices in Drug and Biological Product Postmarket Safety Surveillance
- Safety Considerations for Product Design, Container Labels and Carton Labeling to Minimize Medication Errors
- Process for Nonproprietary Name Suffix Review for Biological Products
- FDA’s Sentinel Initiative and Sentinel’s role in safety surveillance
- Overview of the Division of Risk Management and review activities
- Development of Shared System REMS and waivers
- Best practices for developing and reporting surveys for REMS
- Considerations for REMS Assessments – Planning and Reporting
Who Should Attend?
This event is intended for industry, academia, payors, healthcare information providers, and healthcare providers who:
- review, develop, submit, or use the Prescribing Information, Instructions for Use, and/or carton/container labeling; and
- regulatory affairs professionals specializing in pharmacovigilance and risk management and labeling
- MedDRA Dictionary teams;
- foreign regulators;
- consultants focused on medication errors, REMS, Human factors engineering, and adverse events;
- healthcare professionals specializing in medication errors, REMS, Human factors and adverse events; and
- patient safety organizations.
Continuing Education Credit
- has been pre-approved by RAPS as eligible for credits towards a participant’s RAC recertification upon full completion
- is eligible for SOCRA credit in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area. Candidate must provide documentation of participation.
- has been pre-approved by SQA as eligible for 0.25 non-GCP or non-GLP units for every 1 hour of instructional time towards a participant’s RQAP re-registration.
- is approved for ACRP research-specific continuing education at the completion of this activity. Contact hours are provided at 1 point/hour for at least 45-60 minutes of qualified material.
- Continuing education certificates are available only for those who attend real-time. There is a two week deadline to obtain the certificate of attendance and complete the event survey.
The agenda may be updated. The current version is version 4, updated on May 12, 2020.
The speaker biographies document is under development and will be posted here when it is completed.
The virtual conference will be hosted via Adobe Connect and is limited to 2,000 simultaneous attendees (1,000 each in Room One and Room Two). If a room is full when you attempt to enter, please try the other room. The recordings of each of the sessions will be posted on the Past Events page within 24 hours.
The links below to the Adobe Connect room for each track will be activated shortly before the event begins.
If you encounter any technical issues, visit the Technical Issues Support Page
The above links will becoeme active the day of the event.
The above rooms will open ~15 minutes before each day begins.
Please select the correct room based on your LAST NAME.
The audio for the event will be provided through your computer speakers via Adobe Connect (there will NOT be a teleconference number to dial into). We recommend that you test your PC or mobile device prior to the event and you join the event a few minutes early to address any issues.
To test your PC, please visit:
The ZIP files above will be available for download 24 hours before the event.
The above link will become active at the conclusion of the event.
If you have questions regarding the content of the event or other CDER-specific information, please: