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Now available through Healthcare Learning

Healthcare Learning are now accepting applications for this programme.   Click here for more information and how to apply.

Healthcare Learning brings a wealth of experience, having established itself as a leading provider of undergraduate and postgraduate healthcare education and information over the last 15 years.  It provides blended learning postgraduate degrees collaborating with top universities such as University of Manchester and Plymouth University.   This MSc in Pharmaceutical Medicine is specially geared towards pharmaceutical professionals looking to fast track their careers within the industry.  Click here for more information and how to apply.

Masters in Pharmaceutical Medicine

Hibernia College, in partnership with personnel from Pfizer, Novartis, Sanofi, Quintiles, Icon, Lincoln Research, the EMA, the MCC of South Africa, Eupati, IE Business School, TCD, UWC, University of Basel and the Medical University of Vienna developed the MSc in Pharmaceutical Medicine, a 100% online work-based program that has been described as the ‘Executive MBA of the pharmaceutical industry’.

From Molecule to Medical Application

The two year Master of Science in Pharmaceutical Medicine is suitable for employees in the pharmaceutical, drug development and health-care industries and will give you the essential skills to solve the medical, scientific and economic challenges in today’s industry. You will systematically understand the drug development process from discovery through research and development to regulatory approval and commercialization.

Flexible Pharmacology Study

The program is a 100% online study of pharmacology and clinical trial management within pharmaceutical medicine. It is highly flexible to help balance work, life and study and while the entire masters program takes 2 years, students can take 6 month certificates that build towards the full award.

Global Drug Development Network

Due to the online nature of this program you are interacting with professionals, like yourself, from all over the world. Your studies do not require you to travel or to take any time off work and your company knows you receive the same education whether based in Boston or Bangalore.

Our students come from areas such as medical and regulatory affairs, product and portfolio management, pharmacology, clinical research and drug development, clinical trial management, preclinical research, drug safety, pharmacoeconomics, marketing and market access.

Ethics

Ethics gives the participant an understanding and appreciation of ethical issues that affect the pharmaceutical and health industries. The purpose of medical research is to benefit society by the systematic acquisition of useful, empirical knowledge driven by a desire to understand the causes of disease or dysfunction and find effective methods of prevention or treatment.

In extreme cases, however, even such humanitarian aims can be risky – especially as the very potential for achieving tangible benefits can feed the temptation to press on beyond acceptable boundaries. Arguments about an anticipated greater good are commonly invoked by those willing to sacrifice the rights of research subjects.

In addition to humanitarian aims, scientific curiosity is another major impetus for experimentation. After all, the achievements of modern medicine stem from research and advances which are now taken for granted and were developed through experimentation. For the most part these were probably responsibly conducted according to the standards and theories available at the time. Some research, however, involves such risk or definite harm for the participants that it clearly falls outside all acceptable parameters. Coerced participation in research is clearly abusive but the lack of opportunity to participate can also be so. These are some of the issues addressed in the course.

On successful completion of this module, participants are able to:

  • Evaluate the ethical suitability of research methodologies for the purpose of undertaking research in pharmaceutical medicine especially with respect to vulnerable groups
  • Critically review the ethical issues involved in the undertaking of clinical research
  • Recognise the subjectivity in ethical issues which impact on the research of human and non-human subjects and construct reasonable arguments for their own or others opinion
  • Demonstrate the ability to formulate effective and ethical leadership tools in Pharmaceutical Medicine

Core Competencies in Pharmaceutical Medicine

The aim of this module is to introduce participants to the core competencies in Pharmaceutical Medicine to a level where they can identify the key issues affecting the industry, critically analyse them and begin to reflect upon possible solutions and opportunities.

Upon successful completion of this module the participant is able to:

  • Review the key issues involved in the undertaking of clinical research and development especially in relation to Pharmaceutical Medicine
  • Compare the regulation of medicines in the various global markets
  • Explain the principles of health economics and discuss their application in the development and marketing of medicines

Pharmacovigilence

Pharmacovigilance covers the safety and risk issues that one must address to ensure patients receive safe drugs. This module will give participants a working knowledge of all aspects of drug safety monitoring and risk management and will enable them to predict and analyse drug interactions, and recognise the implications for prescribing and product licence. The participant will also be familiar with pharmacovigilance best practice, including monitoring strategies and action plans and be fully cognisant of regulatory reporting requirements.

At the end of the module, participants can:

  • Appreciate the effect on patient safety and a product’s licence by the different types of adverse events/reactions
  • Identify the key safety reporting requirements, according to the type of adverse event/reaction (in clinical research or in commercial products)
  • Construct and evaluate benefit/risk assessments throughout the lifecycle of a medicine, with reference where applicable to issues around pre- and post-market authorisation

Regulatory Affairs

Regulatory Affairs covers the key regulatory and medical affairs issues affecting the industry today. The course explains the roles of the major regulatory authorities and the regulatory requirements during drug development. Medical information and regulations including prescribing issues and life cycle management are also reviewed in detail.

After successfully completing this module participants are able to:

  • Evaluate the regulatory issues affecting the pharmaceutical industry
  • Compare the regulation of medicines in different global markets
  • Develop and critically appraise product-related information to ensure adherence to ethical and legal provisions
  • Compare and evaluate the different roles of Regulatory and Medical Affairs departments in order to propose consistent strategies involving the marketing of pharmaceuticals, medical information, the role of a pharmaceutical company’s country medical department and licensing agreements

The 10 lessons cover the following topics:

  • Drug Regulation and the Agencies
  • Regulatory Requirements during Drug Development and Marketing Approval
  • Structure of Marketing Authorisation Applications and the role of ICH
  • Chemistry and Manufacturing Control and New Regulatory Approaches to Qualify
  • Post-Approval Regulatory Affairs
  • Intellectual Property and Lifecycle Considerations of Pharmaceutical Products
  • Principles and Practice of Marketing
  • Medical Information and the Regulations
  • The Country Medical Department
  • Emerging Regulatory Issues in Pharmaceutical Development.

Discovery and Formulation of New Medicines

This module provides participants with a systematic understanding of the principles of pharmacology and the mechanism of the action of drugs. During the course of this module, participants will develop a comprehensive understanding of the stages of drug discovery and the mechanism of the action of drugs and will become familiar with the techniques used to identify new drugs and their targets. Participants will learn how to interpret basic research reports originating from the drug discovery process, to evaluate the data and aid in the selection of candidate compounds.

Participants will also develop an understanding of new areas in drug discovery including proteomics, genomics and molecular modelling, and will be able to use data from a range of different areas to understand the mechanism of the action of a drug. Finally, participants will develop an understanding of pharmacology that will allow them to critically appraise pharmacology data and make recommendations on the suitability of a drug for future studies and for clinical development.

At the end of this module, participants are able to:

  • Critically appraise the principle steps in drug discovery based on incomplete and often contradictory data and objectives
  • Evaluate the mechanism of the action of drugs and the techniques used to identify new drugs and their targets
  • Make justified recommendations on the suitability of a drug for future studies and clinical development

Drug Development and Therapeutics

This module will give participants a thorough grounding in the early stages of pharmaceutical research from target identification through human pharmacology studies and the examination of the major therapeutic areas. Therapeutics covers the major diseases, their etiology, epidemiology, pathophysiology, current treatments and their mode of action and possible future cures and preventions. Development focuses on the pharmacological effects that medicines have on the body.

Participants will use the skills that they have developed to evaluate data from a range of different studies, such as various toxicology and pharmacology studies, to select appropriate candidate compounds for clinical study and to develop the appropriate clinical strategy.

Upon successful completion of this module, participants will:

  • Comprehend the key principles of the development of new therapies based on un-met medical needs through the critical evaluation of case studies, research papers and/or research data
  • Evaluate the suitability of research methodologies especially in relation to pharmacology and therapeutic research
  • Comprehend the major therapeutic areas, their epidemiology, pathophysiology, diagnosis, treatment and evaluate opportunities for the industry to meet un-met medical needs in the future
  • Synthesize the different rationales for development plans and be able to construct a plan according to a proposed therapeutic indication

Research Methods

Research Methods teaches the participant not only the critical techniques a scientist needs to know when conducting research but also how to write about his or her research. Not only is this relevant for a dissertation but also for publishing in peer-reviewed journals. A significant amount of cutting edge developments in research and development as well as in health economics and indeed operations are done by industry; however, a large amount of this work goes unreported outside of the professional’s own department, never mind his or her organisation. Professionals in industry therefore require the skills to share their work with others, to communicate their learnings, their discoveries and their failures, thus improving research and thus benefiting the industry as a whole and more importantly, the patient.

This module will introduce participants to methodology and techniques required for successful completion of their research project and develop their ability to identify an appropriate research question and formulate a valid hypothesis. It will also enable participants to design their own research project and manage it in a time-dependent manner in addition to helping them to develop practical skills for data analysis and presentation of results suitable for dissertations and research papers.

After successfully completing this module, participants will be able to:

  • Evaluate the suitability of research methodologies for the purpose of undertaking research
  • Critically review and interpret the literature relating to drug research and development
  • Critically review the ethical issues involved in the undertaking of clinical research
  • Formulate and compare methods for data analysis and the presentation of results and compare different methods when presenting different results
  • Demonstrate the ability to write a research paper by completing at least a hypothesis, an abstract and preliminary literature review

Leadership and Negotiation

Designed for professionals in positions of authority or aspiring to such roles, this course generates essential diagnostic and strategic understanding, as well as personal insight and skills for leadership. Participants are introduced to the theory and practice of negotiation in the context of organisational leadership and management. The purpose is to help professionals strengthen their ability to exercise leadership and negotiate successfully.

Drawing from several disciplines, the course develops a framework for diagnosing and intervening in organisational systems to generate adaptive work. This framework will help participants better analyse negotiations in general and prepare more effectively for future negotiations in which they hope to exercise leadership.

The outcomes of this course include the mastery of a set of practical leadership skills. Students are given the option of completing this module onsite over 5 consecutive days or online. The simulation exercises draw from a wide variety of contexts and their aim is to provide concepts and tools that apply to negotiations that require the exercise of leadership. Through analysis of case studies and discussion of articles on leadership, participants will apply the lessons learned to ongoing, real-world cases.

Upon successful completion of this module, participants will:

  • Demonstrate the ability to judge, select and/or formulate effective leadership tools
  • Demonstrate mastery of a set of practical leadership skills
  • Review, evaluate and propose solutions to scenarios typical for leaders in industry and arrive at possible solutions working in a team environment
  • Recognise the subjectivity in ethical and leadership issues and construct reasonable arguments for one’s opinion or recommendations

Clinical Trials, Knowledge Management and Statistics

The Clinical Trial Management module covers the practical management of the development of a medicine from Phase I to IV using the latest agile and adaptive research techniques to optimise efficiency in the development process. It also teaches participants how to critically review and evaluate statistical data and to leverage the information and knowledge created to contribute to the competitive advantage of their organisation. It is a practical course on how to plan and manage clinical trials cognisant of the pharmacoeconomic conditions and leadership challenges the participant will need to address when leading clinical development programs.

After successfully completing this module, participants will be able to:

  • Critically appraise the principle steps in the clinical trial phases that can often be based on incomplete and sometimes contradictory data and objectives
  • Evaluate the suitability of research methodologies for the purpose of undertaking clinical trials as adaptive as possible
  • Critically review the issues (including legal, ethical, clinical and/or commercial) involved when undertaking clinical trials
  • Demonstrate the ability to plan and develop clinical trials in accordance with legislative requirements and Good Clinical Practice (GCP) procedures
  • Critically interpret and manage statistical data used in clinical development and discriminate between relevant and non-relevant data and be able to justify such decisions

Health Economics

This module will provide the participant with an understanding of the economics affecting the pharmaceutical industry. The development of efficacious, safe, high quality, reliable drugs that meet a medical need must be the primary philosophy of pharmaceutical medicine but it cannot be done without reference to Health Economics. The module will review the importance and impact of healthcare in the economic activity, the functioning of the healthcare market and the health insurance market, the functioning of the pharmaceutical sector and the importance of innovation and the problems of incentives in both the supply and demand of healthcare and pharmaceutical products.

At the end of the module, participants are able to:

  • Evaluate the commercial and pharmaco-economic issues pertaining to drug development
  • Explain the principles of health economics and discuss their application in the development of medicines
  • Evaluate the principles of economics and the methodology behind the statistical and/or data analysis tools used for health economics

Applied Research Project

Research gives scientists, practitioners and policymakers essential knowledge to use in making decisions. Participants will be actively encouraged to contribute to this process and practice it in their professional lives through the research activity that forms a core component of the MSc. in Pharmaceutical Medicine.

The general aims of the applied research project are to develop conceptual and academic rigour in applied research, and to develop participants’ ability in the identification, analysis and presentation of independent applied research through appropriate inferences and recommendations in one of the key subject areas within pharmaceutical medicine.

At the end of the research project, the participant will be able to:

  • Comprehend the principle steps in pharmaceutical research and development based on incomplete and often contradictory data and objectives
  • Evaluate the suitability of research methodologies for the purpose of undertaking research in pharmaceutical medicine
  • Demonstrate expertise in formulating, conducting and reporting an independent and ethical research project
  • Critically review and interpret the literature relating to drug research and development
  • Demonstrate the ability to formulate and employ effective and ethical leadership tools in Pharmaceutical Medicine by completing a substantial body of research
  • Demonstrate the ability to analyse and evaluate data, information and/or surveyed opinions gathered (depending on the nature of the research project) and discuss findings at a level appropriate to a 30 ECTS, Level 9 research project

It should be noted that if a participant does not complete the research project, he or she can still graduate with a Post Graduate Diploma in Pharmaceutical Medicine.

Learning Outcomes

Upon successful completion of the Master of Science in Pharmaceutical Medicine, students can:

  • Understand and assess the principal steps in drug discovery
  • Construct a complete development plan (pharmaceutical, non-clinical and clinical) according to the proposed therapeutic indication
  • Evaluate the pertinent issues involved in the undertaking of clinical research
  • Assess the regulation of medicines in the various global markets and understand how differences can effect drug development, manufacturing and marketing
  • Analyse and manage drug safety issues
  • Review and formulate product-related information to ensure adherence to ethical and legal provisions
  • Understand the principles of health economics and their application in the development and marketing of medicines
  • Lead the management of all lifecycle activities including regulatory and marketing of a medicine
  • Demonstrate advanced and innovative research and development skills, taking drug development to the next level in safety, efficacy and cost-efficiency
  • Critically review and interpret the literature relating to drug research and usage
  • Demonstrate expertise in formulating, conducting and reporting an independent and ethical research project in one of the major subject areas of Pharmaceutical Medicine

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