• NORTH AMERICA • EUROPE • ASIA • RAPS’ Regulatory Convergence - Session Development Template Please complete and return this form to Heather Wakefield at hwakefield@raps.org. Part 1: Session Information Please complete the following information. SESSION TITLE: [50 characters or less] DESCRIPTION: [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)] LEARNING OBJECTIVES: [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…] LEARNING LEVEL: (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 texts. [ ] 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 activity. [ ] 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 • RAPS.org PRODUCT COVERAGE: (Select those that apply) [ [ [ [ [ [ [ [ ] Biologics/Biotechnology ] Health-Related Foods ] IVDs ] Legal ] Medical Devices ] Multiple or Cross-cutting ] Pharmaceuticals ] Regulatory Business GEOGRAPHIC COVERAGE: (Select those that apply) [ [ [ [ [ [ [ [ ] Asia ] North America ] Latin America ] Oceania ] Middle East ] Africa ] Europe ] Global FORMAT: (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 • RAPS.org PowerPoint). They should be concise, informal and inspiring. These presentations may be grouped around common themes or topics depending on the responses received. [ ] Other:____________________________________________ PARTICIPANT ENGAGEMENT: [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. SESSION LEADER AND/OR SPEAKER 1: [Name, Organization, Email Address, Phone] SPEAKER 2: [Name, Organization, Email Address, Phone] SPEAKER 3: [Name, Organization, Email Address, Phone] 5635 Fishers Lane • Suite 550 • Rockville, MD 20852 • USA • Tel +1 301 770 2920 • Fax +1 301 770 2924 • RAPS.org