OCTGT Web Seminar User Survey Your participation/non-participation is completely voluntary and your responses will not have an effect on your eligibility for receipt of any FDA services. All respondent identification and information are confidential and will be anonymous unless otherwise indicated. In instances where respondent identity is needed (e.g., for follow-up of non-respondents), this information collection fully complies with all aspects of the Privacy Act.

1

Your primary affiliation is:

Government

Academic

Private Sector

Non-profit

Other

2

Did you watch:

a) all presentations?

b) only one or more presentations?

3

If you only played a particular presentation(s), which one(s)

Introduction and scope of OCTGT

IND Basics in OCTGT

Sponsor meeting with OCTGT

“361” Human Cell, Tissues & Cellular and Tissue Based Products

CMC Section of a Gene Therapy IND

Advanced Topics: Successful Development of Quality Cell and Gene Therapy Products

Cellular Therapy Products

Preclinical Consideration for Products Regulates in OCTGT

4

How did you find out about this presentation?

Found it through the FDA webpage

Referred to it by an FDA representative during a conference or other public presentation

Referred directly by an FDA representative as a follow up from a prior communication (e.g., telephone or email inquiry)

From a listserv

Referred by a colleague

Other, please specify

5

The level of detail provided was:

Too basic

Too detailed

About right

6

Was the format of the presentations helpful?

Yes

No

7

Guidance documents with additional information were referenced in the presentation. Do you plan to consult any of those guidance documents for further details on specific topics?

Yes

No

Unsure

8

What topics, if any, would you like to see addressed in a web-based seminar in the future?

9

Do you have any additional comments?