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Getting started!

In this very short course, you will get started with an overview of medicines research and development.

(1 Course)

Getting started!

In this very short course, you will get started with an overview of medicines research and development.

Courses:

Overview of Medicines Research and Development

Introduction to Medicines R&D

In this introductory module, you will acquire the basic skills and knowledge about medicines research and ...

(6 Courses)

Introduction to Medicines R&D

In this introductory module, you will acquire the basic skills and knowledge about medicines research and discovery process and find different ways about how patients can be involved.

Courses:

Non-clinical Development

The courses of this module will explain non-clinical studies in detail, the concepts of pharmacogenetics/ge...

(3 Courses)

Non-clinical Development

The courses of this module will explain non-clinical studies in detail, the concepts of pharmacogenetics/genomics and more.

Courses:

Requirements for Non-clinical Studies and the Purpose and Relevance of Animal Testing Development of Medicines Substance and Final Medicines Product Role of Pharmacogenetics / Pharmacogenomics in the Development of Medicines

Clinical Development

This module contains courses on clinical development and trials, including statistics, ethics, the role of ...

(7 Courses)

Clinical Development

This module contains courses on clinical development and trials, including statistics, ethics, the role of participants in trials and more.

Courses:

Clinical Trials and Trial Management Early Clinical Development Trial Participants' Rights & Obligations Ethics Statistics Documentation & Management Interpretation and Dissemination of Results

Regulatory Affairs

The courses in this module will give you an overview on medicines regulation including the different market...

(5 Courses)

Regulatory Affairs

The courses in this module will give you an overview on medicines regulation including the different marketing authorisation procedures, benefit-risk assessment, pharmacovigilance, pharmacoepidemiology and other relevant aspects, and the role which patients can take in these processes.

Important note: term ‘regulations’ can be used in
different contexts while an EU regulation is a legal act of the
European Union that becomes immediately enforceable as law in all member states
simultaneously. EU regulations can be distinguished from EU directives which,
at least in principle, need to be transposed into national law.

Courses:

Introduction to Regulatory Affairs Epidemiology and Pharmacoepidemiology Pharmacovigilance - Risk management Product information and information to the public Regulatory procedures- Marketing-Authorisations and their lifecycle management

Health Technology Assessment (HTA)

The purpose of this module is to introduce you to health technology assessment (HTA). In these courses you ...

(5 Courses)

Health Technology Assessment (HTA)

The purpose of this module is to introduce you to health technology assessment (HTA). In these courses you will learn what a health technology is, what HTA stands for and actually is, and why it is becoming increasingly popular within European health systems.

You will learn best approaches to HTA, and how patients can become involved with HTA within their respective health systems.

Since there is no single approach to HTA, you will learn the different approaches and types of information that are used and what might be thought of as ’best’ approaches. Having an understanding of what health systems need, and how HTA is one key mechanism to address the needs of patients should help to promote and make patient participation in HTA more effective.

Courses:

Introduction to Health Technology Assessment (HTA) HTA Bodies and Principles HTA and Evaluation Methods: Quantitative HTA and Evaluation Methods: Qualitative Patient Involvement in HTA

Medical Devices

The courses in this module will give you an overview on the Medical Devices and their regulatory framework....

(4 Courses)

Medical Devices

The courses in this module will give you an overview on the Medical Devices and their regulatory framework. You will learn about the history of the Medical Devices, different classifications, the role of Notified Bodies and Conformity Assessment, CE marking and re-certification. You will also acquire knowledge about the Medical Devices development and the lifecycle management under the MDR and IVDR and new technologies in the context of Medical Devices and in vitro diagnostics (IVDs). You will learn about the general principles for market access and market access for Medical Devices and the different aspects of Value-based innovation. These courses also provide key definitions about Health Technology Assessment (HTA) in Medical Devices and HTA principles in Medical Devices and in vitro diagnostics (IVDs).

Courses:

Introduction to Medical Devices and their regulatory framework Medical Device development, Lifecycle management, New Technologies, Patient involvement Introduction to market access, key elements and patient involvement Introduction to Health Technology Assessment (HTA) of Medical Devices and IVDs

Digital Health

The courses in this module will give you an overview on the Digital Health and its regulatory
...

(5 Courses)

Digital Health

The courses in this module will give you an overview on the Digital Health and its regulatory
framework. You will
learn about the classification and the impact of the Digital Health and
different examples of the Artificial Intelligence (AI). You will also acquire knowledge
about the digital health applications, infostructure and infrastructure,
and also the development processes in the field. You will learn about the regulatory framework
and the legal aspects of the Digital Health. These courses also focus
on the transformation and the challenges in the Digital Health field and on the
roles of the different stakeholders.

Courses:

Digital Health: Introduction - Classification - Impact Digital Health Applications – Infostructure, Infrastructure Digital Health Development Process Legal, Regulatory, and Health Technology Assessment (HTA) Concepts of Digital Health Digital Health Transformation and challenges