Session Development Template

RAPS’ Regulatory Convergence - Session Development Template
Please complete and return this form to Heather Wakefield at
Part 1: Session Information
Please complete the following information.
[50 characters or less]
[100-250 words to address how participants will benefit from
attending this session (not just what they will learn, but how they
can apply what they will learn to their job and career)]
[2-3 objectives should be developed to highlight the instructional
content and/or expected outcomes in terms of knowledge and
skills. The objectives must be clear and attainable and should
answer the following statement: Upon completion of this session,
participants should be able to…]
(Select those that apply)
[ ] Basic
Content is introductory in nature and requires no requisite
knowledge or experience to grasp concepts or related exercises.
Basic educational activities, books and other products are meant
to establish a foundation of knowledge and/or competence that
will be expanded upon in practice or in higher level activities or
[ ] Intermediate
Content is appropriate for individuals who have basic knowledge
of the topic(s) and/or demonstrated competence related to the
topic(s). For courses and other educational activities, higher-level
concepts are introduced during lectures and exercises requiring
synthesis and/or application of concepts are incorporated into the
[ ] Advanced
Content is intended for individuals who are well-versed in most, if
not all, concepts associated with the topic(s). Activities and texts
emphasize analysis and application of concepts or demonstration
of competencies. For activities, this is typically done through
exercises such as case studies, scenario building and group
projects. In these activities, a high level of participation is
expected from each attendee.
5635 Fishers Lane • Suite 550 • Rockville, MD 20852 • USA • Tel +1 301 770 2920 • Fax +1 301 770 2924 •
(Select those that apply)
] Biologics/Biotechnology
] Health-Related Foods
] IVDs
] Legal
] Medical Devices
] Multiple or Cross-cutting
] Pharmaceuticals
] Regulatory Business
(Select those that apply)
] Asia
] North America
] Latin America
] Oceania
] Middle East
] Africa
] Europe
] Global
(Select preferred format)
[ ] Round table
This is a structured discussion on a key learning topic or challenge
that in a small, focused group of colleagues. This type of session
will be led by one or more senior learning executives, who will
present a short overview of the key questions and then engage
the audience in an exploratory conversation. These are held in
medium to smaller rooms in order to facilitate participation.
[ ] Panel discussion
Led by a key industry leader, these sessions bring together
several experts and colleagues with diverse experiences around a
central theme or challenge.
[ ] Case study
Problem-based session, where a situation is presented with
specific examples and data, the situation is analyzed to determine
what happened, and a well-thought-out solution or
recommendation is made.
[ ] How-to session
Pragmatic sessions that provide practical advice and suggested
actions or steps to successfully implement and/or utilize strategies
to execute the intended objective.
[ ] Debate
These are sessions surrounding an area of controversy where two
sides of an issue are presented.
[ ] Series of short-form conference presentations (15–20
minutes each)
These are presentations given in an innovative and engaging way
(e.g. careful use of images or illustrations rather than death by
5635 Fishers Lane • Suite 550 • Rockville, MD 20852 • USA • Tel +1 301 770 2920 • Fax +1 301 770 2924 •
PowerPoint). They should be concise, informal and inspiring.
These presentations may be grouped around common themes or
topics depending on the responses received.
[ ] Other:____________________________________________
[100-250 words to describe your plan for achieving the learning
objectives through an engaging and dynamic learning
environment. Learner involvement increases the level of learning;
therefore, session designs should incorporate elements such as
knowledge checks, interactive group work, etc.]
Part 2: Recommended Faculty
Identify appropriate experts to serve as session speakers. Please note that each session should
contain a maximum of three faculty (including the session leader and speakers). It is also our goal to
provide balance in the sessions (e.g. speakers from different companies, perspectives, etc.) Feel free
to reach out informally to confirm participation first and then provide details to RAPS staff so formal
invitations can be extended. Please note: If you would like to include a speaker from a health authority,
official invitations and confirmations will be handled by RAPS.
[Name, Organization, Email Address, Phone]
[Name, Organization, Email Address, Phone]
[Name, Organization, Email Address, Phone]
5635 Fishers Lane • Suite 550 • Rockville, MD 20852 • USA • Tel +1 301 770 2920 • Fax +1 301 770 2924 •