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A Global Perspective on Conducting Early Access Programs

25

Speaker:
Bruce Schechter

Early Access includes a variety of programs by which pharmaceutical companies make investigational therapies available to patients with life-threatening diseases. These patients have either exhausted available treatments or have no approved options. This presentation will review the processes and procedures to consider in the implementation of an Early Access Program and explore the opportunities and challenges posed therein.

Learning Objectives:

At the end of this webinar the participant will be able to:

  • List the differences between an early access program and a clinical trial
  • Compare the different types of early access programs
  • Describe the components needed to implement an early access program
  • Understand how local laws and regulations govern the conduct of an early access program
  • Understand the benefits and drawbacks of conducting an early access program

 

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Not a MAPS Member but Want to View?

Membership is only $250 USD per year ($425 for a 2-year subscription) and includes access to all new live Webinars, all on-demand Webinars (over 50 Webinars and growing each month), discussion forums to share best practices and questions with over 4,000 Medical Affairs professionals from across the globe, copies of past meeting presentations, white papers, standards & guidance tools and templates, and much, much more. Click here for membership details or to sign up: https://medicalaffairs.org/membership/

 

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Patient Engagement in Drug Development: An Opportunity for Medical Affairs

28

Speakers:
Mary Alice Dwyer, PharmD
Jamie Kistler, PhD
Tricia L. Gooljarsingh, PhD, CMPP

This eCadmey Webinar features insights from three senior subject matter experts, and provide an opportunity for live discussion and questions on this important topic.

LEARNING OBJECTIVES
At the conclusion of this eCademy Webinar, participants will be better able to understand:

  • the numerous ways in which partnership with patients can impact the development and commercialization of medicines
  • the current “patient centric” landscape in pharmaceutical drug development, including the patient perspective of clinical trial conduct, recent findings related to the value of patient-centric trial design, and innovative approaches to engaging with patients across the study continuum
  • key considerations for patient engagement in clinical trials

 

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Not a MAPS Member but Want to View?

Membership is only $250 USD per year ($425 for a 2-year subscription) and includes access to all new live Webinars, all on-demand Webinars (over 50 Webinars and growing each month), discussion forums to share best practices and questions with over 4,000 Medical Affairs professionals from across the globe, copies of past meeting presentations, white papers, standards & guidance tools and templates, and much, much more. Click here for membership details or to sign up: https://medicalaffairs.org/membership/

 

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Field Based Medical LCM in the Device and Pharma World

32

Speakers: Kevin Appareti and Suzanne Giordano, PhD

OVERVIEW

As healthcare continues to transform, we need to stay connected to our customers in many ways. From Upstream scientific exchange driving research, to clinical trial design establishing evidence, to co-creation workshops establishing value propositions, to education and post-release support to drive adoption, collaboration with customers across the solution lifecycle is key to providing the best solutions to our customers. MSLs are becoming more important and playing key roles across the lifecycle in partnership with many others who play important roles. We will describe the landscape, drivers, and opportunities for engaging with customers across the lifecycle and how we socialize learnings across the organization.

LEARNING OBJECTIVES

  • Understand the different drivers of increased value in Medical Affairs
  • Opportunities for gathering insights across the solutions lifecycle
  • Roles participating across the solution lifecycle in a medical device company

 

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Not a MAPS Member but Want to View?

Membership is only $250 USD per year ($425 for a 2-year subscription) and includes access to all new live Webinars, all on-demand Webinars (over 50 Webinars and growing each month), discussion forums to share best practices and questions with over 4,000 Medical Affairs professionals from across the globe, copies of past meeting presentations, white papers, standards & guidance tools and templates, and much, much more. Click here for membership details or to sign up: https://medicalaffairs.org/membership/

 

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Dust Off Your Scientific Communication Platforms: Updating, Implementing, and Operationalizing Them for Success

33

Speakers: Tricia Gooljarsingh, PhD, CMPP and Jamie Kistler, PhD

The Scientific Communication Platform (SCP) is the foundation of a strong medical communications strategy for a pharmaceutical product or device, and serves as an important tool to align communications and messaging across functional areas. Even minor discrepancies in cited data and/or the way that data are described can lead to confusion and weaken a product’s overall value proposition. The SCP is based on scientific evidence and requires an in-depth analysis and review of available and anticipated data, the disease and competitive landscape, stakeholder perceptions, and aspirations about the product profile. Since the final SCP output ensures accurate and consistent language and referencing through all communication activities, putting a plan in place to ensure successful cross-functional and regional implementation and utilization of this valuable resource is critical.

 

Learning Objectives

After completing this Webinar, participants will be better able to:

  • Ensure understanding of the basic components and processes involved in the development of a scientific communication platform (SCP)
  • Understand how to develop and/or update an SCP so that the scientific and value narratives are integrated
  • Learn how to train and implement an SCP across functional teams
  • Glean insights into tailoring a global SCP to a regional SCP
  • Understand the challenges of metricizing an SCP and practical solutions for measuring effectiveness

 

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Not a MAPS Member but Want to View?

Membership is only $250 USD per year ($425 for a 2-year subscription) and includes access to all new live Webinars, all on-demand Webinars (over 50 Webinars and growing each month), discussion forums to share best practices and questions with over 4,000 Medical Affairs professionals from across the globe, copies of past meeting presentations, white papers, standards & guidance tools and templates, and much, much more. Click here for membership details or to sign up: https://medicalaffairs.org/membership/

 

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Clinical Statistics for Non-Statisticians (Part 1 of 2)

26

OVERVIEW

This series will provide you with tools to critically process and analyze medical scientific literature. You will get a good understanding of basic statistical concepts and theory that enable you to explain, understand and interpret data. These Webinars are practical and based on published articles and the analysis of these. You will work with the theory in practice to increase your understanding of the strengths and weaknesses of the statistics in scientific literature.

LEARNING OBJECTIVES – Part 1

  • To define some terminologies in statistics
  • To explain different types of data (quantitative vs. qualitative)
  • To describe different ways in presenting summary data (such as proportions, means, medians, range and standard deviation)
  • To explain 95% confidence intervals
  • Bivariate analyses and appropriate statistical testing for quantitative and qualitative variables

 

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Not a MAPS Member but Want to View?

Membership is only $250 USD per year ($425 for a 2-year subscription) and includes access to all new live Webinars, all on-demand Webinars (over 50 Webinars and growing each month), discussion forums to share best practices and questions with over 4,000 Medical Affairs professionals from across the globe, copies of past meeting presentations, white papers, standards & guidance tools and templates, and much, much more. Click here for membership details or to sign up: https://medicalaffairs.org/membership/

 

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Value Assessment for Health Technologies – A Primer on Cost-Effectiveness Analysis and Health Technology Assessment

65

Health technology and value assessment can be conducted using a variety of methods. Dr. Malone will provide an overview of those methods and an introduction on how to interpret the results from cost-effectiveness studies. This webinar will also discuss issues with defining value for health technologies, especially pharmaceuticals.

 

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Not a MAPS Member but Want to View?

Membership is only $250 USD per year ($425 for a 2-year subscription) and includes access to all new live Webinars, all on-demand Webinars (over 50 Webinars and growing each month), discussion forums to share best practices and questions with over 4,000 Medical Affairs professionals from across the globe, copies of past meeting presentations, white papers, standards & guidance tools and templates, and much, much more. Click here for membership details or to sign up: https://medicalaffairs.org/membership/

 

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Truth Hunting: Leave No Stone Unturned in Defining Impactful Medical Affairs Strategies

34

Speakers: Ian Greenway, Angel Riggins, and Amanda Foote

The Medical Affairs function has broadened beyond medical excellence and increased in strategic importance over recent years, and is under increasing pressure to prove the value of products to a wider, more diverse group of stakeholders. A rigorous, intensive process is vital for successful insight mining and landscape analysis. Leave no stone unturned – from a product’s scientific differentiators right through to the macro-level forces that shape HCPs and patients’ lives, attitudes, and behaviors in the therapy area. Taking a truly holistic view of a product’s attributes and challenges informs the most effective and affective product strategies. The most impactful strategies have the desired positive change in healthcare firmly at their core.

 

Learning objectives:

  • Look beyond the traditional elements of landscape analysis to consider valuable cultural, behavioral, and situational insights
  • Understand the power of truths in defining the meaningful difference your product will make in patients’ lives
  • Understand the key ingredients of a robust and impactful Medical Affairs strategy and how to implement it

 

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Not a MAPS Member but Want to View?

Membership is only $250 USD per year ($425 for a 2-year subscription) and includes access to all new live Webinars, all on-demand Webinars (over 50 Webinars and growing each month), discussion forums to share best practices and questions with over 4,000 Medical Affairs professionals from across the globe, copies of past meeting presentations, white papers, standards & guidance tools and templates, and much, much more. Click here for membership details or to sign up: https://medicalaffairs.org/membership/

 

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“MSLs Rattling the Cage” – break out roles, strategic innovation and building excellence for Field Based Medical

37

Speakers: Helen Kane, Robin L. Winter-Sperry, MD and Ramin Farhood, PharmD, MBA

Participants of this Webinar an will:

  • Gain tips and tricks for communicating cross-functionally the value of Field Based Medical
  • Enhance your business acumen and ability to leverage the business through science and effective strategy
  • Learn about demonstration of value and how to measure it and to hire, train and retain towards that goal

 

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Not a MAPS Member but Want to View?

Membership is only $250 USD per year ($425 for a 2-year subscription) and includes access to all new live Webinars, all on-demand Webinars (over 50 Webinars and growing each month), discussion forums to share best practices and questions with over 4,000 Medical Affairs professionals from across the globe, copies of past meeting presentations, white papers, standards & guidance tools and templates, and much, much more. Click here for membership details or to sign up: https://medicalaffairs.org/membership/

 

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Medical Device Meritocracy | A Triad of Value

40

Speaker: John B. Pracyk, MD, PhD, MBA, FAANS, FACS
Integrated Leader, Medical Affairs, Pre-Clinical & Clinical Research, DePuy Synthes – Spine, Johnson & Johnson Medical Devices Companies

The medical device industry is facing challenging times ahead. A broader set of influencers (regulators, hospital administrators and other value-orientated customers) will see a shift from individual outcomes to a focus on population-led effectiveness and will require the development of comprehensive value propositions for any device or drug.

In addition, sweeping reform of the rules that govern the medical device industry in Eu-rope represents one of the most disruptive changes to affect the global medical technology sector in recent times. Under the European Medical Device Regulation, companies will have three years to comply with a broad swathe of new rules for almost every kind of product in the medical device spectrum. How do medical device manufacturers deal with a decidedly more frugal and selective customer base? This webinar looks at serving the needs of all stakeholders by helping to ensure that the company gets safe, reliable products to market efficiently and cost-effectively—without any barriers to clearance.

 

Learning Objectives:
After participating in this Webinar, participants will be better able to:

  • Understand the development of Value Analysis in integrated delivery networks
  • Understand Design to Value for OEM Medical Device Manufacturer
  • Develop comprehensive value propositions for any device or drug
  • Understand how the new Medical Device Regulation (MDR) will drive global value, specifically:
    • State of the Art
    • Device Classifications
    • Evidence Generation
    • Equivalent Comparator
    • Post Market Surveillance & Follow Up
    • Data Mining and Requirements

CLICK HERE TO VIEW IN THE COMMUNITY PORTAL

 

Not a MAPS Member but Want to View?

Membership is only $250 USD per year ($425 for a 2-year subscription) and includes access to all new live Webinars, all on-demand Webinars (over 50 Webinars and growing each month), discussion forums to share best practices and questions with over 4,000 Medical Affairs professionals from across the globe, copies of past meeting presentations, white papers, standards & guidance tools and templates, and much, much more. Click here for membership details or to sign up: https://medicalaffairs.org/membership/

 

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Medical Affairs Excellence and Ethics & Compliance in the Evolving Healthcare Landscape – Collaborating and Leading by Example

60

Speakers: Mónica de Abadal, MD and Giota Papamarkou

Life science companies are facing unprecedented change requiring a rapid evolution of the Medical Affairs function. Patients are at the centre of Medical Affairs mission, which is the basis for ethical decision making and conduct of activities. Medical Affairs excellence is also achieved by following robust Ethics and Compliance principles and therefore leading by example within the organization.

Without doubt, a close collaboration between Medical Affairs and Ethics and Compliance functions for achieving excellence in Medical Affairs and beyond is needed.

 

Learning Objectives:

By participating in this Webinar, attendees will be able to understand the importance of E&C in Medical Affairs and the amount of topics that this can cover

  • The role of Medical Affairs in guiding ethical decisions internally and externally
  • The impact of Medical Affairs beyond its remit
  • Importance of sharing best practices for the role of Medical Affairs in strategic brand planning, and the ethics and compliance considerations for Medical Affairs plans
  • And many other hot topics such as pro-active and reactive scientific exchange

 

CLICK HERE TO VIEW IN THE COMMUNITY PORTAL

 

Not a MAPS Member but Want to View?

Membership is only $250 USD per year ($425 for a 2-year subscription) and includes access to all new live Webinars, all on-demand Webinars (over 50 Webinars and growing each month), discussion forums to share best practices and questions with over 4,000 Medical Affairs professionals from across the globe, copies of past meeting presentations, white papers, standards & guidance tools and templates, and much, much more. Click here for membership details or to sign up: https://medicalaffairs.org/membership/

 

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