2018 RAPS Convergence Submission Preview

Proposal Title

Your title must be less than 20 words and should describe the nature of the presentation.

Examples: Regulatory Considerations in Clinical Study Design; Labeling as a Driver of Regulatory

and Commercial Strategy

Geographic Coverage

Select the proposal’s geographic coverage. (Note: Select all that apply)

  • North America
  • Europe
  • Asia
  • Latin America
  • Oceania
  • Middle East
  • Africa
  • Global

Learning Level(s)

Select the most appropriate learning level. (Note: Select all that apply)

  • Basic: Content is introductory in nature and requires no prior knowledge or experience to grasp concepts or related exercises.
  • Intermediate: Content is appropriate for individuals who have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s).
  • Advanced: Content is intended for individuals who are well-versed in most/all concepts associated with the topic(s).

Session Type

Select one of the following presentation formats:

Featured session

  • Length: 60 minutes
  • Number of speakers: 1 – 3 (2 – 3 recommended)
  • Suggested emphasis or approach: 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. Could possibly have attendees in small groups and report back to the entire group.

Idea exchange session

  • Length: 30 minutes
  • Number of speakers: Only 1 speaker
  • Suggested emphasis or approach: These are presentations given in an innovative and engaging way (e.g., careful use of images or illustrations instead of text-dense slides). They should be concise, informal, and inspiring.

Soapbox session

  • Length: 30 minutes
  • Number of speakers: 1-2
  • Suggested emphasis or approach: These sessions provide an opportunity for the presenter(s) to provide their opinion on a hot or recent topic, with the expectation of soliciting opposing views from the audience.

Statement of Need

In less than 100 words, describe why this topic is important for the regulatory professional.

Example 1: Each year, the Food and Drug Administration (FDA) issues hundreds of warning letters to

medical device companies for reasons ranging from manufacturing practice violations to breaches in

labeling and misbranding. Companies responding well to the FDA’s demand for prompt compliance will

ultimately return to the agency’s good graces and through the experience develop processes that result

in better business both culturally and financially. But getting to that point may be a slippery slope if the

issues in the letter are not addressed effectively and expediently.

Example 2: Medical device reimbursement can be a significant barrier to market entrance. A knowledge

of the reimbursement status of a new device is an important component of a product’s marketing

strategy, and development of a reimbursement strategy early in the product life cycle can greatly

accelerate commercial acceptance.

Description

In 100 – 300 words, describe how participants will benefit from attending this session. (HINT: Don’t focus only on what they will learn, but how they can apply what they will learn to their job and career.)

Example 1: Design and selection of clinical endpoints almost always spark a lively debate and regulatory professionals are key participants in the discussion. Selection of key endpoints acceptable to health authorities, and also to support the company’s marketing claims, is of paramount importance. This session will discuss strategic approaches to selecting key primary endpoints for novel or preventative therapies, especially those not covered specifically by regulatory guidance or reference products. The session also will include the European Union perspective on novel therapies. In addition, the value of the Food and Drug Administration and European Medicines Agency Drug Development Tool/Novel Methodologies Qualification process will be presented as it relates to clinical endpoint selection.

Example 2: The goal of drug product development is creating a safe and effective product with global commercial success. Continuous alignment of key stakeholders over the development timeline is essential to ensuring optimal labeling from approval through lifecycle management. This session will describe the target product profile (TPP) process and its use in early label development to the company core data sheet (CCDS), including a case study of how the label is used as a driver in regulatory and commercial strategy. Get an in-depth look at labeling compliance expectations from the emerging markets and steps to keep up to date on global products within country-specific environments.

Learning Objectives

Learning objectives outline the knowledge or skills that those who attend your presentation should have after listening. They help prospective attendees know what they will gain from your session and also help the Convergence Planning Committee to understand on what things you will focus.

Example:

Upon completion of this session, participants should be able to:

  • Describe at least three common sense points to remember while establishing a constructive working relationship with the FDA.
  • Explain how to move forward with better business practices that are balanced and compliant to regulation.

For your proposal, provide 2-3 objectives.