Syllabus

Ethics gives the participant an understanding and appreciation of ethical issues that currently 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 will be 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

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 will be 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

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 should be able to:

• 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

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 will be 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

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

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. To obtain this outcome, this 5-day course will combine seminar-based sessions with role playing and leadership simulations. 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

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

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 will be 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

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.

Ethics gives the participant an understanding and appreciation of ethical issues that currently 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 out- side 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 will be 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

· Recognize 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