This series of the Elevate Podcast illuminates the path scientific communication takes from teaching to diagnosis to treating all the way to changing, prolonging, and saving patient lives.
From space biology to patient voice to best practices for onboarding, here are highlights of the APPA/MAPS Joint Medical Affairs Summit in Sydney, Australia.
Introduction to external Education eLearning Course
Free to Members and Non-Members
If you are new to Medical Affairs, just getting started in developing your skills in medical education, or want a quick refresher, sign up for this e-learning module which provides an introduction and overview of all the different types of industry approaches to External Education (EE). The course will help you:
Learning activities/assessments: eLearning self-paced module with knowledge checks and a brief posttest
Approximate time to complete the activity: 30 minutes
Prerequisites: None
Audience: Beginner to Intermediate; For any Independent Medical Education (IME) and/or Medical Affairs professionals involved in External Education
Learning Objectives:
At the conclusion of this online learning activity, participants should be able to:
Activity Developers:
MAPS is appreciative of the following MAPS members and other individuals who were instrumental in creating the course content.
Independent Medical Education eLearning Course
FAWG Group: External Education
Member: Free
Non-Member: 135$
Interested in broadening your understanding of the different types of External Education in the spirit of omnichannel engagement, and more specifically in Independent Medical Education? Designed Specifically for Medical Affairs professionals working in the Independent Medical Education (IME) function, as well as, other MA Professionals involved in External Education (EE), This course:
The one-hour course will assist organizations to not only understand the breadth and depth of IME but also plan for upskilling their team as needed and enhance collaboration with other Medical Affairs and cross-functional partners to leverage synergies.
Learning activities/assessments: eLearning self-paced module, knowledge checks, and brief posttest (moderate difficulty)
Approximate time to complete the activity: 60 minutes
Prerequisites: The eLearning module “Introduction to External Education” is highly recommended.
Audience: Beginner to Intermediate; For any Independent Medical Education (IME) and/or Medical Affairs professionals involved in External Education
At the conclusion of this online learning activity, participants should be able to:
ACTIVITY DEVELOPERS:
MAPS is appreciative of the following MAPS members and other individuals who were instrumental in creating the course content.
At the MAPS 2022 Global Annual Meeting in New Orleans, we sat down with Medical Affairs leaders in attendance to discuss a range of issues important to the function. Now as we prepare for the MAPS 2023 Global Annual Meeting in Nashville, March 26-29 (early bird registration open until December 31!), join us in looking back at these important opinions. Have a topic you’d like covered at the 2023 meeting? Email MAPS Communications/Marketing Director, Garth Sundem, with your suggestions!
It is hard to overstate the expansion of Real-World Evidence (RWE) over the last 5 years. ISPOR has designated RWE the #1 trend in Health Economics for 2022-2023. Most new drug and biologics applications to FDA now include RWE information.
The use of RWE to support product label expansion has been a primary driver of interest in RWE. The 21st Century America Cures Act, enacted in 2016, required FDA to evaluate RWE in support of new drug indications. Since the Cures Act, FDA has issued multiple guidances and draft guidance statements regarding use of RWE for regulatory applications. The Agency has also utilized RWE in approving expanded indications for drug products. As FDA states at the top of its RWE web page, “Real-world data (RWD) and real-world evidence (RWE) are playing an increasing role in health care decisions.”
This virtual presentation will focus on 3 aspects of RWE:
1) What are RWE and Real-World Data (RWD), and how are they different?
2) What are relevant legal and regulatory considerations associated with using RWE for product label expansion?
3) How have applicants successfully used RWE to obtain approval for new drug and medical device indications?
In every successful organization there are fundamental business processes that create value and deliver a desired output. In life science companies, one of these processes is called commercialization. Commercialization of a health care product begins from the moment of concept creation. At that point, the innovator is thinking about how to treat a disease, make a patient’s life better, or meet an unmet medical need. Over time, value is built into the asset as it moves through the product development/commercialization pathway. Medical Affairs has a key role in this product development/commercialization pathway. Often referred to as a bridge between product development and commercial, Medical Affairs contributions are essential to deliver a successful commercialization process. Understanding the commercialization process and the role Medical Affairs plays in the overall organization will assist Medical Affairs professionals to make better decisions and optimize their ability to influence the future direction of their company.
This webinar seeks to help Medical Affairs professionals better understand the business of life science companies, how their efforts impact the overall capability to commercialize a product, and contemporary ways to bridge the commercialization interface between their department and Marketing & Sales. Topics included are a discussion on organizational operations and throughput, the importance of understanding the organization/enterprise main functions and how Medical Affairs aligns with functions, and optimizing interface between commercial and Medical Affairs. Our discussants will take a Medical Affairs-centric approach to discussing business operations management issues which should be useful for all Medical Affairs functions but particularly operations, therapeutic area leadership, and aspiring Medical Affairs managers.
Upon completion of the webinar, participants should be able to:
This webinar will discuss how MA colleagues are best positioned to explore the fusion of PE and PED in the post-launch phase, including generation and use of RWD and RW evidence, and will share guidance and information on several industry-supported resources, to enable MA colleagues to implement PE and evidence strategies in their function. Importantly, patient and patient advocate perspectives will also be considered, sharing opportunities, and best practice examples of how MA colleagues can overcome perceived barriers, to achieve true and impactful PE.
Following the presentation, participants will have a greater understanding of:
- Current best practice in patient engagement, from both an industry, patient advocate and patient perspective
- The convergence of patient experience data, real world evidence and patient engagement activity and why this is important to Medical Affairs
- What patients and their advocates need from their industry partners for better patient engagement and how this is likely to evolve
- The specific impact patient engagement can have on a Medical Affairs strategy and the various research, tools and guidance available to support this
The webinar discusses how to engage with Digital Opinion Leaders (DOLs) and how they can be a valuable source of insights, with a strong focus on the compliance aspects. Increasing numbers of pharma stakeholders are active in social media and thereby present an open and accessible opportunity for the gathering of insights. When Pharma listens to these DOLs it needs to be done in a compliant way. The same applies to the engagement with DOLs. The webinar addresses these topics and the important role Medical has to play when listening and engaging with DOLs.
Based on discussions between 80 cross-industry Field Medical colleagues from small to large biopharmaceutical and medtech companies, this article highlights key actions for Medical Affairs teams to consider for implementation in their own organizations.