Share your expertise and take your place among our profession’s experts. Your perspectives are valuable to the profession’s field of knowledge. Review the information below on presentation preparation. Submit a presentation proposal

Please note: Submissions must be made by 30 November.

• Presentations sought
• Speakers sought
• Benefits of presenting
• Training level
• Taxonomy
• Writing session descriptions
• Writing learning objectives
• Selection process

I. Suggesting a RAPS presentation

A. Presentations Sought

RAPS’ program committees seek presentations that reflect:

• issues and perspectives demonstrating measurable impact and results;
• global issues addressing implications of our international community;
• implications from healthcare agencies, regulatory and legislative bodies;
• emerging corporate trends in pharmaceuticals, medical device and biologics;
• case studies, innovations and best practices, as well as current research.

Training Format

• Face-to-face meetings: Sessions are either 60 or 90 minutes in length and encompass product areas, lifecycle stages and other skill areas such as Devices, Drugs, Biologics, Clinical, Combination Products and Regulatory Business. View track definitions
• Webcasts: Each Webcast is 90 minutes in length, focusing on specific interest areas as Regulatory Updates, Hot Topics, RAC Preparatory, Risk Management, Good Laboratory Practices, Medical Devices, Regulatory Law, Prescription Drugs, Region-Specific, Biologics and many more.
• Breakfast Roundtable Discussion*: These small group discussions provide an opportunity for attendees to discuss new developments, legislation and collaborations with RA experts in the field.

*Please note that Roundtable Facilitators do not receive a complimentary registration nor a discount.

B. Speakers Sought

RAPS’ program committees seek speakers who:

• are cutting edge, proven leaders in their field;
• are practitioners with strong first-hand experience and knowledge of the topic;
• have faced obstacles and solved real problems;
• have adapted and introduced new programs, products, procedures or practices;
• are able to share their knowledge from a realistic, hands-on perspective.

C. Benefits of Presenting:

Benefits of presenting at a RAPS program:

• Complimentary (or reduced) program registration fee.
• Recognition before, during and after the program as a subject-matter expert.
• Contribution to furthering professional development of RA colleagues.
• Contribution to the body of knowledge for RA professionals.
• Unparalleled access to corporate and regulatory professionals, as well as global healthcare agencies’ officials.
• Gain RAC recertification points.

II. Completing a Presentation Proposal

A. Training Level

• Level I: Individual has limited or no knowledge of RA, and he or she has no experience in the industry or the RA field. He or she has some experience in related fields (e.g., medicine, engineering or chemistry).
• Level II: RA professional has basic knowledge and skills in RA. At this level, the RA professional completes the RAC certification. He or she has broad knowledge across the product line. He or she has some experience in related functional areas (e.g., quality assurance, clinical or R&D).
• Level III: RA professional has developed a broad spectrum of knowledge and skills (professional & interpersonal) that allow him or her to perform duties. This level requires practice, support to improve and maintain skills and knowledge. Professionals are primarily involved with technical issues, both on operational and management levels.
• Level IV: RA professional demonstrates a high level of RA knowledge, experience and a deep level of skills (professional, interpersonal & leadership). He or she focuses on executive, strategic and management issues.

B. Taxonomy

RAPS’ taxonomy for the focus of your topic:

Products

Biologics
Allergenic
Blood
Cellular & Gene Therapy
Tissues
Vaccines
Xenotransplantation
Cosmetics
Combination Products
Drugs
Generic Drugs
Orphan Drugs
Patent Drug/New Drug/Brand Name Drug
Over-the-Counter (OTC)
Food
Medical Devices
Class I
Class II
Class III
Veterinary Medicine

Professional Responsibilities (Regulatory process)

Biological License Approval (BLA)
Investigational New Drug ( IND)
Investigational Device Exemption (IDE)
Good Laboratory Practice (GLP)
Good Clinical Practice (GCP)
Good Manufacturing Practice (GMP)
New Drug Approval (NDA)
Postmarket Surveillance
Premarket Approval (PMA)
Premarket Notification (510K)
Quality System (QS)
Registration Establishment

Professional Responsibilities (Production)

Conception and Development
Research
Preclinical/Nonclinical Study
Clinical Trial
Submission/Registrations
Manufacture
Manufacturing
Packaging
Labeling
Marketing/Promotion
Advertising
Promotion
Marketing
Distribution/Sale
Postmarketing
Postmarketing Surveillance
Reporting
Tracking

Other Professional Responsibilities

Strategic Planning
Management
Reimbursement
Ethics
Crisis Management/Risk Management
Negotiation
Trade
Training/Educating
Career
Employment
Nanobiology
Nanobiotechnology
Nanodevices
Nanomedicine
Nanotechnology

Geographic Areas

Africa
Asia
China
India
Japan
South Korea
Australia/Oceania
Australia
New Zealand
Europe
North America
United States
Canada
South America
International
International Conference Harmonization (ICH)
World Health Organization (WHO)

C. Writing Session Descriptions

1. Tips for writing session descriptions

• Write a clear and concise session description.
• Highlight the following areas: the topic’s importance/need, content overview, target audience description and how this topic will help the target audience.
• Write in the present tense.

2. Sample Session Description

Current good manufacturing practices (cGMPs) define acceptable standards for all aspects of biopharmaceuticals manufacture—and their proper interpretation and application is critical for meeting regulatory expectations. This session presents the history of GMP, rationale behind cGMPs, FDA regulations, European regulations and similarities and differences. It is beneficial for RA and QA professionals.

D. Writing Learning Objectives

1. Tips for writing learning objectives

• Write three learning objectives from the perspective of the learner (not your presentation objectives).
• Make objectives action- or results-oriented, using leading words like apply, analyze, discuss, develop, examine, explore, identify, recognize, etc.
• Avoid passive words like learn, understand and know.
• Answer this question to help you craft your objectives: What will the learner know or be able to do after attending the session? (i.e., “Design creative learning experiences” rather than “Learn creative techniques to design learning experiences.”)
• Make sure that you can deliver on the objectives you choose.

2. Sample learning objectives

The session/seminar will help participants to:

• expand their regulatory perspective throughout the product lifecycle;
• develop and present the strategies needed to ensure regulatory compliance and achieve marketing authorizations;
• utilize their technical expertise and competence and exercise their negotiating skills in a peer environment.

III. Selection Process

• Acknowledgment of receipt will be sent indicating the review timeline.
• Proposal will be reviewed by program committee members and RAPS education team.
• Selection will be based on relevance, quality and available space.

Submit a presentation proposal