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Courses

All face to face courses are accredited by the Austrian "Akademie der Ärzte".

 

The aim of the course is that students have a working knowledge of:

  • Clinical Research, a Historical Review
  • Study Design Types
  • New Drug Development
  • The Phases of Clinical Research
  • Clinical Trial Design
  • Short Introduction to Good Clinical Practice
  • Protection of Clinical Trial Participants
  • Fraud and Misconduct
  • Safety Reporting in Clinical Trials
  • Quality Management

On successful completion of this course, students should be able to:

  • describe the goals of clinical research and the process of a clinical study
  • be familiar with the international guidelines (Declaration of Helsinki, ICH-GCP Guidelines ), their development and influcne on the regulations.
  • know the role and mission of the ethics committee  like the protection of well-beeing, autnonomy and integraty of the clinical trial participants.
  • fullfil the etical and  formal needs of the informed consent process especially with respect to vulnerable groups
  • apply the structure and content of a study protocol to the own project.
  • demonstrate the ability to understand the context between correct data entry and data quality  as well as avoid mistakes when designing CRFs and questionnairs.
  • implement the basic principles of quality management and understand the increasing measures of monitoring.

The aim of the module is that students should have a working knowledge of:

  • The History and Principles of GCP
  • GCP Terminology
  • Investigator Responsibilities
  • Safety Reporting
  • Essential Documents
  • Sponsor Responsibilities
  • Ethics Committee Responsibilities
  • Informed Consent
  • Applicable Regulations and International Differences – Overview
  • Challenges to Apply GCP & The Players and the Process
  • Ensuring High Quality Data (Source documents/CRFs/eCRFs) in Clinical Trials
  • Improving Safety Reporting in Clinical Trials
  • Patient Information and Informed Consent
  • Audits and Inspections Readiness
  • Communication Challenges
  • Internal Quality Control/Monitoring
  • Misconduct in Clinical Research

On successful completion of this course, students should be able to:

  • demonstrate the ability to plan and devlelop clinical trials in accordance with the legislative requirements and Good Clinical Practice (GCP) procedures.
  • formulate the knowledge of the applicable ethical regulations.
  • draft methods of creating a study plan.
  • recognise the patient protection.
  • critically appraise the handling of drugs in clinical trials.
  • be familiar with the investigator and sponsor responsibilities.
  • discuss frequently encountered problems and sources of error in connection with patient information sheets, side effect of drugs, study reports, source data management, ethics commission notices.
  • apply the legal regulations and the current status of the implementation of international GCP Guidelines.

The aim of the course is that students should have a working knowledge of:

  •     Medical Data
  •     Descriptive statistics for qualitative data
  •     Sampling error for continuous data, confidence interval for the mean
  •     Descriptive statistics for categorical/binary data
  •     Sampling error and confidence intervals for point estimates
  •     Describing and testing between groups for continuous variables
  •     Describing and testing differences between groups for categorical variables
  •     Correlation and Regression
  •     Paired experiments and the paired t-test

On successful completion of this course, students should be able to:

  • critically interpret and manage statistical data used in clinical development discriminate between relevant and non-relevant data and justify such decisions.
  • interpret results and effectively manage data.
  • apply standard statistical methods for simple but relevant situations.
  • describing and testing continuous and categorical variables.

The aim of the course is that students should have a working knowledge of:

  • Getting Started with Epidemiology
  • Selecting the Study Population
  • Risk Factors, Endpoints and their Measurement
  • Measures of Frequency, Association and Impact
  • Sampling error and confidence intervals for point estimates
  • Interpreting an Effect I and Effect II
  • Study Design Types
  • Cohort Study & Case Control Study
  • Clinical Trial Protocols: Points to Consider
  • Blinding and Randomization
  • Use and Ethics of Controls in Clinical Trials
  • Superiority and Equivalence: Problems and Switching
  • Outcome Parameters

On successful completion of this course, students should be able to:

  • understand the scientific logic and ethical aspects of clinical research.
  • know the methodological principles of clinical epidemiology.
  • calculate basic outcome metrics and effect measures.
  • critically appraise random variability, bias, and confounding.
  • know about principles of surveillance, cross-sectional, case-control, and cohort studies.
  • Understand the methodological key elements when designing a clinical study.
  • critically appraise epidemiological and clinical studies.
  • have a solid understanding of design principles of randomised trials.
  • name problems and pitfalls in conducting clinical studies.

The aim of the course is that students should have a working knowledge of:

  • “Study Protocols” - Finding the Rationale
  • Writing the study synopsis with reference to the PICO format
  • Surrogate and clinical endpoints in Cardiovascular studies
  • Statistical issues for clinical study protocols
  • Useful templates for Protocols and Informed consent
  • Guidelines for Diabetes Studies
  • In- Exclusion Criteria
  • Introduction to Medical Devices
  • Distribution of Responsibilities
  • What are the costs of my study?
  • Update on the clinical trials regulation
  • Regulatory framework of the medical devices sector
  • Protocol Writing

On successful completion of this module, students should be able to:

  • developing a study protocol in their own particular field of interest
  • develop the ability to understand the basic concept of the various clinical study protocols
  • write protocol synopsis and study protocol according to standardized formats
  • critically review statistical issues for clinical study protocols
  • evaluate the regulatory framework of medical devices

The aim of the course is that students should have a working knowledge of:

  • The Peer Review Process and Publication Ethics
  • Data Selection and Primary Structuring – The Story line
  • Literature Research, Journal Selection, Guidelines to Authors
  • Results Section – Tables, Figures & Legends
  • Method Section – Basic Research, Clinical Research
  • Discussion Section
  • Some Secrets of an easy-to-read Text
  • Introduction Section
  • Abstract Section
  • Title and Authors
  • Institution, Keywords, Acknowledgements, Reference List
  • Short Formats
  • Revising the rough draft
  • Style and Language
  • Submission to Journal, Cover Letter
  • How to deal with Referee Comments, Response Letter
  • Statistical Methods and Presentation of Statistical Results
  • The CONSORT Statement

On successful completion of this course, students should be able to:

  • understand the peer review process and critically review the publication ethics involved
  • select a suitable journal for the publication of the arcitle
  • demonstrate the ability to write a scientific article by completing at least an introduction section, abstract, method section and discussion section
  • submit a scientific article at a journal including a cover letter and deal with the referee comments
  • Critically evaluate the short formats: commentary, case report etc.

The aim of the course is that students should have a working knowledge of:

  • Practically significant difference, equivalence and non-inferiority
  • Relative Risk & Odds Ratio and their confidence intervals and Number Needed to Treat
  • Randomization methods, stratification, blinding
  • Missing data, Intention to Treat versus Per Protocol, Full analysis sets
  • SPSS
  • Analyses of variance
  • Analyses for paired data (Paired t and McNemar’s tests)
  • Study types (Pros and cons)
  • Correlation and regression
  • Analysis of covariance
  • Multi-center Studies
  • Bayes theorem and diagnostic tests
  • Measures of agreement - Cronbach alpha and Cohen kappa
  • Statistical analysis process - Protocol and Statistical Analysis Plan etc.
  • Non-parametric methods
  • Multiple testing
  • Survival analysis
  • Stratified analysis - Mantel-Haenszel
  • Logistic Regression
  • Meta-analysis
  • Interim analysis, group sequential and adaptive designs

On successful completion of this module, students should be able to:

  • exploit the greater generalizability and more rapid recruitment available with multi-centre studies
  • select appropriate methods of subject randomisation
  • use measures such as Relative Risk etc to express the clinical significance of a trial using a dichotomous end-point
  • calculate and interpret measures of agreement such as Cronbach’s alpha and Cohen’s kappa
  • identify trial structures that are appropriately analysed by more advanced statistical procedures such as analysis of variance, correlation & regression, analysis of covariance, the paired t & McNemar’s tests, logistic regression, survival analysis, non-parametric methods and stratified analyses such as Mantel-Haenszel
  • use SPSS to carry out the analyses mentioned above.
  • understand the difference between Intention to Treat and Per protocol analyses and when each is most appropriately applied

The aim of the course is that students should have a working knowledge of:

  • Types of Publications other than RCTs/Papers
  • Applying the STROBE Guidelines
  • Research Integrity
  • Guidelines for Publications (COPE, Helsinki, etc.)
  • Perfecting your papers
  • How to avoid plagiarism in the master thesis
  • Reviewing for a Journal
  • Authorship and co-authorship rules and responsibilities
  • How to survive a Peer Review
  • Bring your own text: analysis of your writing
  • Searching Scientific Literature  and Databases
  • Case Reports
  • Writing and Creating Posters for Meetings
  • Writing Style/Avoiding Mistakes
  • Communication your Results to the Public
  • Presentation Skills “The art of presenting”
  • Review Articles, Meta-analysis and Systematic Reviews

 

On successful completion of this module, students should be able to:

  • understand what makes scientific writing clear and to learn simple techniques for effective communication in writing
  • understand the rules and conventions of research publication and appreciate what journals expect of authors
  • be aware of ethical issues in research and publication and understand guidelines on authorship
  • master some basic techniques for overcoming stress when delivering oral communications.
  • learn how to develop and present oral communications illustrated with clear and effective slides
  • learn the general public’s prejudices and misunderstanding about science and medicine in order to be able to best communicate important medical information to them

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

On successful completion of this module, students should be able to:

  • evaluate the commercial and pharmacoeconomic 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

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

On successful completion of this module, students should 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 research of human and non-human subjects and construct reasoned arguments for their own or others opinion
  • demonstrate the ability to formulate effective and ethical leadership tools in Pharmaceutical Medicine

The aim of the course is that students should have a working knowledge of:

  • critically interpretation of study cases from the literature in which students will be able to take the role of supporter or critic
  • discussion with the tutor or the course director of the individual study plan, the progress, the master thesis, and any issues relative to different modules

On successful completion of the tutorials, students should be able to:

  • critical interpretation of articles in journals
  • identifying arguments for and against in the article
  • presentation and support for arguments
  • discussion of the counterarguments

The aim or the course is that students feel confident in writing their master´s thesis.

In this workshop the progress in writing the master´s thesis is accompained.

Questions are discussed and uncertainties in the field of statistics are claified, too.

The aim of the course is that students have a working knowledge of:

  • Medical Affairs in the context of pharmaceutical industry while reflecting all current national and international regulations and guidelines
  • the role of Medical Affairs in drug development and the cooperation with Marketing & Sales, Regulatory & Pharmacovigilance as well as with academic institutions
  • different job profiles and practical tasks in Medical Affairs and furthermore on collaboration with healthcare professionals and other stakeholders

On successful completion of this course, students should be able to:

  • get an understanding of the international pharmaceutical market and of the importance of internal and external communication and team- and networking on national and international level
  • to draw up a rough medical affairs plan

The aim of this course is to give students a working knowledge of the:

  • safety and risk issues that must be addressed to ensure that patients receive safe drugs.
  • aspects of drug safety monitoring and risk management.
  • pharmacovigilance best practice, including monitoring strategies and action plans, and be fully cognisant of regulatory reporting requirements

On successful completion of this module, students should be able to:

  • evaluate the safety and regulatory issues pertaining to drug development with respect to safety and surveillance issues
  • appraise and compare the regulation of medicines in the various global markets with respect to safety and risk management
  • comprehend the effect that different types of adverse events/reactions have on patient safety and a product’s licence
  • identify key safety reporting requirements according to the type of adverse event/reaction (in clinical research and commercial products
  • construct and evaluate benefit/risk assessments throughout the life cycle of a medicine, with reference where applicable to issues around pre-and post-market authorisation

The aim of this course is to give students a working knowledge of the:

  • essential diagnostic and strategic understanding
  • personal insight and skills for leadership
  • theory and practice of negotiation in the context of organisational leadership and management

 

On successful completion of this module, students should be able to:

  • 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
  • recognize the subjectivity in ethical and leadership issues and construct reason arguments for their opinion or recommendations           

The aim of this course is to give students a working knowledge of the:

  • the regulatory environment around the world
  • regulations and their practical application
  • the impact of the development programme on the final label
  • current issues affecting Regulatory Affairs

On successful completion of this module, students should be able to:

  • evaluate the regulatory issues affecting the pharmaceutical industry
  • compare the regulation of medicines in different global market
  • develop and critically appraise product-related information to ensure adherence to ethical and legal provisions
  • compare and evaluate the different roles of Regulatory and/or 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 aim of the course is that students should have a working knowledge of the:

  • the principles of pharmacology and the mechanism of action of drugs
  • the stages of drug discovery and the mechanism of action of drugs andthe techniques used to identify new drugs and their targets
  • new areas in drug discovery including proteomics, genomics and molecular modelling
  • use data from a range of different areas to understand the mechanism of action of drugs
  • 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

On successful completion of the tutorials, students should be able to:

  • interpret basic research reports originating from the drug discovery process.
  • to evaluate the data and aid in the selection of candidate compounds
  • critically appraise the principal steps in drug discovery based on incomplete and often contradictory data and objectives
  • evaluate the mechanism of 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

The aim of this course is to give students a working knowledge of the:

  • elements necessary in the integrated development of a new drug from identifying therapeutic needs to clinical pharmacology through Phase I to IV
  • principles of proof of concept studies, dose ranging studies and bioequivalence studies as well as pharmacokinetics, pharmacodynamics, metabolism and excretion and the influence that they have on clinical development

 

On successful completion of this module, students should be able to:

  • describe the key steps in the development of new therapies 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
  • describe the epidemiology, pathophysiology, diagnosis and treatment of a therapeutic area and propose opportunities to prevent, cure or treat a disease
  • synthesize different rationales for development plans and be able to construct a plan according to a proposed therapeutic indication

The aim of this course is to give students a working knowledge of the:

  • methodology and techniques required for successful completion of a research project
  • identification of an appropriate research question and formulate a valid hypothesis
  • design of an own research project and manage it in a time-dependent manner.
  • critical evaluation of relevant literature
  • practical skills for data analysis and presentation of results suitable for dissertations and research papers

On successful completion of this module, students should be able to:

  • evaluate the suitability of research methodologies for the purpose of undertaking research
  • critically review and interpret literature relating to drug research and development.
  • critically review 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