CONVERSATIONS THAT MATTER

Join RAPS Fellows and senior regulatory professionals for informal discussions on key challenges facing today’s regulatory professionals. These sessions are not recorded and no slides will be presented, but are a relaxed setting for informal conversations with industry leaders. Come prepared to ask your questions and share your personal insights. Each session is open to everyone at all career levels, but seating is limited and is managed on a first-come, first-served basis.

MONDAY, 11 SEPTEMBER
7:30 am–8:15 am

Conversations That Matter 1: Interactions With Health Authorities

The way you communicate and establish your relationship with regulatory agencies could make or break your professional reputation. Every interaction with health authorities provides an opportunity to build your credibility. The panel of regulators and industry from around the world, including FDA, EMA and HC, join RAPS attendees in an interactive discussion that includes open question and answer, policy updates, agency collaborations and current trends. We want to hear from you during this informal session. There is no presentation, so come prepared with your questions or discussion topics. 


Conversations That Matter 2: TransCelerate Biopharma Inc.—How 18 Companies are Collaborating on Global Regulatory Engagement With an Aim to Improve Clinical Research

TransCelerate BioPharma Inc., launched in 2012, is a non-profit organization created with the vision to improve the health of people around the world by accelerating, simplifying and enhancing the research and development of innovative new therapies. TransCelerate is known for their ability to work harmoniously with various stakeholder groups within the clinical research ecosystem which is central to the organization’s strategy. One key stakeholder group is Global Health Authorities, who are critical to building innovative, industry-transforming solutions. TransCelerate established a Regulatory Council in early 2013, with the mission to advise the many TransCelerate Initiatives and the Oversight Committee on regulatory strategies and processes, and deliver engagement approaches for collaborating with Health Authorities around the world. In addition, they identify how the initiatives align with the Health Authority objectives. In this session, panelists will discuss details of the novel approaches for regulatory engagement and share success stories from several of initiatives.



3:00–3:45 pm

Conversations That Matter 3: 101 Ways to Develop an Exciting Regulatory Career

In this session, RAPS Fellows will facilitate informal discussions on strategies in career development and how they transitioned and repurposed skills from their lifecycle of learning. Discussion topics will include appropriate training and credentials (RAC, certificate, master’s degree), the importance of developing a professional network, and best ways to use social media.



TUESDAY, 12 SEPTEMBER
7:30 am–8:15 am

Conversations That Matter 4: FDA's Newly Launched Oncology Center of Excellence

This session explores the structure and function of the newly formed FDA Oncology Center of Excellence (OCE). The OCE leverages the combined skills of regulatory scientists and reviewers with expertise in drugs, biologics and devices (including diagnostics) to expedite the development of oncology and hematology products for the treatment of cancer. 



3:00–3:45 pm

Conversations That Matter 5: Interactions With Health Authorities

The way you communicate and establish your relationship with regulatory agencies could make or break your professional reputation. Every interaction with health authorities provides an opportunity to build your credibility. The panel of regulators and industry from around the world, including FDA, EMA and HC, join RAPS attendees in an interactive discussion that includes open question and answer, policy updates, agency collaborations and current trends. We want to hear from you during this informal session. There is no presentation, so come prepared with your questions or discussion topics.