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To encourage a diverse set of presenters, the following restrictions will apply. Each individual may do any or all of the following activities labeled (a), (b), or (c):

(a) Parallel sessions
1. Organize up to two sessions or have any other active role in up to two parallel sessions with the following restrictions* (see #2–#5)
2. Chair† only one session, which can be a session they organized
3. Give a presentation in only one session, but not in a session for which they are serving as chair
4. Serve as a panelist in only one session, which could be in the same session in which they present
5. Serve as a discussant in only one session, but not in the same session in which they present or chair

(b) Roundtable leader
Lead one roundtable discussion

(c) Short course teacher
Teach one short course

Under (a), a person cannot hold multiple roles within one session. For example, one person cannot serve as both the chair and a speaker in the same session. However, the session’s organizer may serve as a presenter, discussant, panelist, or chair in that session, but not more than one of these roles.

For example, it is possible for the same person to do at most the following: organize one session; be the chair of the session he/she organizes and be the presenter in another session; lead one roundtable; and teach one short course.

† The chair is responsible for keeping time for each presentation, introducing the speakers, and starting and ending the session on time.

Plenary session: Being a speaker or panelist of a plenary session is considered being invited and therefore exempted from the rules above. It can be done in addition to any of the roles in (a), (b), and (c).

Diversity: To ensure diversity of speakers’ affiliations, every session must have at least one presenter from industry and one from the FDA. A third speaker from academia is ideal, but not required for all sessions. If two or more speakers/panelists are from industry, they must be from different companies.

* Because FDA participants are in high demand, these restrictions may be suspended for FDA participants to ensure FDA presence at the workshop with approval from the workshop co-chairs.