Erica M. Katherine, Associate Ombudsman, FDA-ORA, invites you to reserve a session to discuss your specific questions one-on-one, or with your team, so she can focus on you, your company, and your concerns. All 15-minute sessions occur on Tuesday, March 17, 2020, at Xavier University's Cintas Center.
You must be a PharmaLink main conference sessions participant to sign up for office hours.
Sessions are reserved on a first-come, first-served basis.
One session per company.
Two appointments cannot be combined.
You may bring a team, but each team member must be an PharmaLink main conference sessions attendee.
If you are attending the Supplier Quality Workshop or Risk, Metrics and Culture: Empowering your Organization Workshop, you may still sign up for an Office Hours appointment.
Each person joining the appointment must be listed in the reservation form.
What is an Ombudsman?
An Ombudsman is a neutral, impartial person who investigates and settles disputes and resolves complaints. The Office of Regulatory Affairs (ORA) Ombudsman’s Office serves as a one-stop-shop for informal advice or consultation for external stakeholders who have complaints or inquires.
The ORA Ombudsman is dedicated to two primary objectives:
Informally address concerns, complaints, and other issues that arise between ORA and stakeholders outside of the Agency, including industry, governmental organizations (federal, state, territorial, and tribal), and other members of the public; and
Engage in outreach and education for these stakeholders and employees of ORA to enhance communication and transparency with stakeholders.
The ORA Ombudsman abides by ethical principles and standards established by the Coalition of Federal Ombudsmen, the U.S. Ombudsman Association, and the International Ombudsman Association. These include standards for ensuring confidentiality, neutrality, and informality.