{"id":3217,"date":"2021-08-16T16:19:49","date_gmt":"2021-08-16T14:19:49","guid":{"rendered":"https:\/\/vscr.at\/?page_id=3217\/"},"modified":"2021-08-16T16:20:54","modified_gmt":"2021-08-16T14:20:54","slug":"content-and-curriculum","status":"publish","type":"page","link":"https:\/\/vscr.at\/en\/medical-affairs\/content-and-curriculum\/","title":{"rendered":"Content and Curriculum"},"content":{"rendered":"<h4 id=\"ma-module1\"><strong>MODULE 1<\/strong><\/h4>\n<h3><strong>Introduction to Medical Affairs and Medicines Development &#8211; The role of \u00a0medical affairs in a changing world<\/strong><\/h3>\n<p><strong>The drug development process<\/strong><\/p>\n<ul>\n<li><strong>Product life cycle<\/strong>\n<ul>\n<li>The discovery process and non &#8211; clinical development<\/li>\n<li>Principles of toxicology and toxicokinetics<\/li>\n<li>Principles of genomics and pharmacogenetics: personalized medicine<\/li>\n<\/ul>\n<\/li>\n<li><strong>Disease models and target identification<\/strong><\/li>\n<li><strong>Clinical and Translational research and basic biostatistics:<\/strong>\n<ul>\n<li>Principles of translational research: from bench to bedside<\/li>\n<li>Biomarkers and surrogate endpoints in clinical research<\/li>\n<li>Experimental design and basic biostatistics<\/li>\n<\/ul>\n<\/li>\n<li><strong>Clinical research<\/strong>\n<ul>\n<li>Ethics<\/li>\n<li>GCP<\/li>\n<li>Hierarchy of CTs (phases of CTs with special emphasis on Phase III and Phase IV)<\/li>\n<li>Data capture\/handling<\/li>\n<li>Role of local management vs. corporate processes<\/li>\n<li>Protocol development (phase IV and investigator &#8211; initiated trials)<\/li>\n<li>Analysis<\/li>\n<li>Reporting<\/li>\n<li>Publication<\/li>\n<li>Use of data for commercialisation<\/li>\n<li>Issue management<\/li>\n<li>DOs and DONTs in clinical research<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><strong><u>Learning outcomes Module 1<\/u><\/strong><\/p>\n<ul>\n<li><em>Outline the steps in the pharmaceutical development of a drug substance and the final product<\/em><\/li>\n<li><em>Outline the design of clinical trials, including legal, regulatory, ethical and practical aspects<\/em><\/li>\n<li><em>Describe the influence of genetic factors in drug development and drug response<\/em><\/li>\n<li><em>Analyze and compare the principles and applications of statistics in clinical trials<\/em><\/li>\n<li><em>Describe the principles and operational aspects related to intellectual property, patents and <\/em><\/li>\n<li><em>Summarize the key documents related to the ethical conduct of clinical trials<\/em><\/li>\n<li><em>Outline the Investigators Brochure sections and describe its use, approval and <\/em><\/li>\n<li><em>Revise the principles and practical relevance of ethical issues in biomedical research and the legal and ethicalprovision for the protection of clinical trial subjects.<\/em><\/li>\n<li><em>Identify the key issues involved in the conduct of a clinical study including investigator and site selection, sitemanagement and conflict <\/em><\/li>\n<li><em>Describe the procedures for clinical trial data collection and data management to ensure optimal quality dataand outline the various quality management issues in clinical <\/em><\/li>\n<li><em>Outline the various quality management issues in clinical trials<\/em><\/li>\n<li><em>Discuss the collection, evaluation and reporting of adverse event data in clinical trials<\/em><\/li>\n<li><em>Explain the role of governance committees during the study conduct<\/em><\/li>\n<li><em>Discuss the evaluation and interpretation of clinical trials results<\/em><\/li>\n<\/ul>\n<p><em>\u00a0<\/em><\/p>\n<hr \/>\n<h4 id=\"ma-module2\"><strong>MODULE 2<\/strong><\/h4>\n<h3><strong>Medical Approval of marketing and sales material, sponsoring activities, medical eventsusing international standards <\/strong><\/h3>\n<ul>\n<li><strong>Principles and practice of marketing<\/strong>\n<ul>\n<li>The role of Medical Affairs<\/li>\n<\/ul>\n<\/li>\n<li><strong>Advertising and promotion and promotional review<\/strong>\n<ul>\n<li>The development of promotional materials before review<\/li>\n<li>Regulations and Codes of Practice<\/li>\n<li>Good promotional practices<\/li>\n<li>Review Committees<\/li>\n<\/ul>\n<\/li>\n<li><strong>The MSL function<\/strong>\n<ul>\n<li>The need for MSLs in a changing global landscape<\/li>\n<li>Roles and responsibilities, education and training<\/li>\n<li>Different customers and alignment across channels<\/li>\n<li>Scientific exchange and insight analysis concepts<\/li>\n<\/ul>\n<\/li>\n<li><strong>Medical Multi-Channel Communication<\/strong>\n<ul>\n<li>Strategy<\/li>\n<li>Implementation<\/li>\n<li>Management<\/li>\n<\/ul>\n<\/li>\n<li><strong>Standards<\/strong>\n<ul>\n<li>International standards<\/li>\n<li>Relations to FDA standards<\/li>\n<li>Internal standards and compliance rules<\/li>\n<li>Local standards GCC countries<\/li>\n<li>Organisational recommendations\/ archiving\/ issue management<\/li>\n<\/ul>\n<\/li>\n<li><strong>Business case and practical examples<\/strong><\/li>\n<li><strong>DOs and DONTs and issue management in medical approval<\/strong><\/li>\n<\/ul>\n<p><strong><u>Learning outcomes Module 2<\/u><\/strong><\/p>\n<ul>\n<li><em>Summarize the principles of medical\/marketing and the role of Medical Affairs<\/em><\/li>\n<li><em>Understand the processes of development and review of product information to ensure compliance to ethical, legal and regulatory principles pertaining to Good Promotional Practices and marketing activities<\/em><\/li>\n<li><em>Appraise the contributions of the various medical affairs related functions (medical information, medical communication and education, medical service liaisons, external affairs, strategic alliances, ) to asuccessful business conduct within the organization<\/em><\/li>\n<li><em>Critically appreciate a Multi-Channel Communication strategy<\/em><\/li>\n<li><em>Understand the role of Medical Affairs in the life-cycle management of medicines (with clinical, regulatory and marketing), different types of data generation and the role of the medical affairs function<\/em><\/li>\n<li><em>Discuss the role of generics and biosimilars<\/em><\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<hr \/>\n<h4 id=\"ma-module3\"><strong>MODULE 3<\/strong><\/h4>\n<h3><strong>Creating a high &#8211; performance organization in Medical Affairs and Medicines Development<\/strong><\/h3>\n<ul>\n<li><strong>Public and Professional Relations<\/strong>\n<ul>\n<li>Role of Patient and Patient Organizations<\/li>\n<li>Professional Associations and academic institutions<\/li>\n<li>Key Opinion leaders contacts and relations<\/li>\n<li>Government relations<\/li>\n<li>Communication strategies<\/li>\n<li>The basics of adult education and continuing professional development, Accreditation, Certification<\/li>\n<li>Conflicts of interest: academia, professional associations and industry<\/li>\n<li>Medical Education within pharmaceuticals<strong>\u00a0<\/strong><\/li>\n<\/ul>\n<\/li>\n<li><strong>Management Issues in Medical Affairs<\/strong>\n<ul>\n<li>RWE<\/li>\n<li>Crisis management<\/li>\n<li>Controlled medicines<\/li>\n<li>Drug abuse and dependence<\/li>\n<li>Patent protection and price management<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><strong><u>Learning outcomes Module 3<\/u><\/strong><\/p>\n<ul>\n<li><em>Integrate the principles and practices of people management and leadership to apply within their own workingenvironment<\/em><\/li>\n<li><em>Describe the principles and processes needed to develop an effective medical business plan<\/em><\/li>\n<li><em>Describe quality and project managements tools as well as performance improvement concepts to addressorganizational performance<\/em><\/li>\n<li><em>Outline the value of networks and strategic alliances to meet the business objectives<\/em><\/li>\n<li><em>Discuss the role of patients and professional organizations in health care<\/em><\/li>\n<li><em>Appraise the contributions of some medical affairs related functions (to a successful business conduct within the organization<\/em><\/li>\n<li><em>Ensure the various functions within the organization are aligned to achieve the business and professional goals<\/em><\/li>\n<li><em>Compare the processes of production and review of product information to ensure compliance to ethical, legal and regulatory principles<\/em><\/li>\n<li><em>Describe the ethical issues and ongoing tensions between the need for financial incentives for clinical researchand medicines development and the global need for affordable medicines<\/em><\/li>\n<li><em>Describe the principles of professionalism, assessment of competence and identity formation to guide the practice of medical affairs in medicines <\/em><\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>MODULE 1 Introduction to Medical Affairs and Medicines Development &#8211; The role of \u00a0medical affairs in a changing world The drug development process Product life cycle The discovery process and non &#8211; clinical development Principles of toxicology and toxicokinetics Principles of genomics and pharmacogenetics: personalized medicine Disease models and target identification Clinical and Translational research<a class=\"excerpt-read-more\" href=\"https:\/\/vscr.at\/en\/medical-affairs\/content-and-curriculum\/\" title=\"ReadContent and Curriculum\">&#8230; Read more &raquo;<\/a><\/p>\n","protected":false},"author":6,"featured_media":0,"parent":3214,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-3217","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/vscr.at\/en\/wp-json\/wp\/v2\/pages\/3217","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/vscr.at\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/vscr.at\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/vscr.at\/en\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/vscr.at\/en\/wp-json\/wp\/v2\/comments?post=3217"}],"version-history":[{"count":3,"href":"https:\/\/vscr.at\/en\/wp-json\/wp\/v2\/pages\/3217\/revisions"}],"predecessor-version":[{"id":3220,"href":"https:\/\/vscr.at\/en\/wp-json\/wp\/v2\/pages\/3217\/revisions\/3220"}],"up":[{"embeddable":true,"href":"https:\/\/vscr.at\/en\/wp-json\/wp\/v2\/pages\/3214"}],"wp:attachment":[{"href":"https:\/\/vscr.at\/en\/wp-json\/wp\/v2\/media?parent=3217"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}