Professional Education, Capabilities and Identity in Medical Affairs

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Objectives:

MA has seen an exponential growth over the last decade as it value and place within the pharmaceutical industry is being realised. The evolution of MA from a support function to strategic partner has changed the direction of MA and also required an evolution of skill sets for the roles which underpin MA.

As a profession, there is still a void with a globally recognised advanced scientific qualification, capability frameworks across the main 3 role types and accreditation.

This collaborative webinar aims to discuss available postgraduate courses and insights from alumni into how their qualification helped advance their understanding of pharmaceutical medicine and their career.

  • • Understand what educational opportunities are open to MA professionals and also those aspiring to enter the profession
  • • Comprehend the content of programmes and how it relates to roles
  • • Discuss the future of MA in terms of universal recognition of a base qualification which can then be regionally adapted

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Strategic Planning_Standards for Medical Affairs

Medical Affairs Strategic Planning Guide and Templates

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Strategic Planning_Standards for Medical Affairs

Objectives:

The Medical Affairs teams demonstrate leadership and value each year through the annual strategic planning process that aligns all multifunctional MA competencies on common objectives needed to support the product and organization. A focused and cohesive medical strategy must be developed to navigate the complex therapeutic environment for each product – overcoming challenges, taking advantage of opportunities and filling any scientific or clinical gaps. A comprehensive and supportive tactical plan aligned to the medical strategy should define the activities that will provide the most impact and benefit to stakeholders in therapeutic space while taking the MA team one-step closer to achieving annual goals.

The MAPS Medical Affairs Strategic Planning Guide and Template has been developed to provide guidance and recommendations to selected components that comprise the strategic medical affairs planning for a product – including the situational analysis, medical strategy, tactical/operational planning, and medical plan summary.

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Understanding AI And ML And Potential Applications For Medical Affairs

Understanding AI and ML And Potential Applications For Medical Affairs

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Objectives:

Understand the latest technologies—Artificial Intelligence (AI), Machine Learning (ML), Natural Language Processing (NLP), and Natural Language Understanding (NLU). Understand the potential of these technologies to increase efficiencies, enhance effectiveness and potentially reduce compliance risk.

At the conclusion of this session, participants should:
• Better understand contemporary digital trends of Artificial Intelligence (AI), Machine Learning (ML), Natural Language Processing (NLP), and Natural Language Understanding (NLU)

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27

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

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Objectives:

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.

Statistical analysis in clinical trials

– Null/alternative hypotheses

– Statistical assumptions (type I error, significance level, type II error, statistical power,)

– Hypothesis testing

– Statistical tests

Statistics used in RCTs

– Type of outcome measures (dichotomous, continuous, time-to-event)

– Statistics used for analysis of dichotomous data (relative risk, odds ratio, risk difference, NNT)

– Analysis of time-to-event variables (plotting and interpretation of Kaplan-Meier curves)

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25

A Global Perspective on Conducting Early Access Programs

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Objectives:

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.

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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28

Patient Engagement in Drug Development: An Opportunity for Medical Affairs

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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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33

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

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Objectives:

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.

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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26

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

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Objectives:

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.

  • • 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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