Training

Online statistical training is available through Smerud's sister company Statinet (Norway).

In addition, our International office in Oslo (Norway) includes a conference centre, enabling us to host seminars with a capacity of up to 60 people.

REGULAR EVENTS


Seminars: Clinical Research
Informal monthly meetings covering various aspects of clinical trials and regulatory affairs.
Twice a year, they focus on good clinical practice (GCP).

Courses: GCP Training
These quarterly courses are mainly focused on educating study nurses, investigators and clinical research associates in the discipline of good clinical practice. We are also able to adapt a course for your specific needs.

To find out more about any of our seminars or training courses, please contact us.

PROGRAMME - 2008


Clinical Trials: An Introduction

DATES OF COURSE
2-3 March 2009
18-19 May 2009
31 August - 1 September 2009          

DEADLINE FOR REGISTRATION
6 February 2009
24 April 2009
14 August 2009

  • For study nurses and study coordinators
  • Theoretical lectures and practical workshops
  • Topics: General terminology, drug development, regulations, applications and procedures for approval, protocol, informed consent document, investigator's brochure, trial setup, trial conduct, AE/SAE reporting, trial closure.
  • Fee: NOK 3.500 (includes lunch)

 

FULL COURSE LIST

 

Course # 1. Overview of clinical development of drugs

Duration: 4 hours
Contents:
This basic training course will give an introduction to clinical research.
Topics to be reviewed are:

  • Drug development and the pharmaceutical industry
  • Clinical trial stages
  • Regulation of clinical research
  • Common methodology concepts
In addition a brief overview of the most important principles from GCP (Good Clinical Practice) guidelines will be given.

 

Course # 2. European pharmaceutical law

Duration: 4 hours
Contents:
This training course will give a brief introduction to the main legal framework for the pharmaceutical industry.
Important European regulations and directives will be reviewed.
Notice of Applicants will be presented.

 

Course # 3. Guidelines for good clinical practice

Duration: 8 hours
Contents:
In this training course the guidelines for Good Clinical Practice (ICH topic E6) will be reviewed in detail using examples from real life and case discussions.
Topics to be covered are:

  • Principles and definitions
  • IRBs/ethics committees
  • Investigator’s responsibilities
  • Sponsor’s responsibilities
  • Clinical trial protocols
  • Investigator’s brochure
  • Essential GCP documents

 

Course # 4. General considerations for clinical trials

Duration: 6 hours
Contents:
In this training course general considerations for clinical trials will be reviewed. ICH guideline E8 with the same title as the training course will form the background of the presentation.
Topics to be covered are:

  • General principles of clinical trials
  • Development methodology, including:
    • non-clinical studies to be performed
    • requirements to quality of study drug
    • phases of clinical development
    • special considerations for individual trials and drug development programs.

 

Course # 5. Structure and content of clinical study reports

Duration: 4 hours
Contents:
In this training course you will learn about the requirements to clinical study reports as outlined in ICH guideline E3.
You will also get practical tips for how to write a good report.

 

Course # 6. Dose response information to support drug registration

Duration: 4 hours
Contents:
In this training course you will learn about the requirements to dose response information to support drug registration as outlined in ICH guideline E4.
Topics to be covered are:

  • The purpose of dose ranging trials
  • Choice of starting dose and dose increments
  • Study designs for dose response studies
  • Dose-response, concentration-response
  • Brief overview of pharmacokinetic principles

 

Course # 7. Statistical principles for clinical trials

Duration: 6 hours
Contents:
This training course will review ICH guideline E9 (Statistical principles for clinical trials).
Topics and principles to be covered are:

  • avoiding bias
  • design configuration
  • multicentre trials
  • type of comparison
  • group sequential designs
  • sample size estimation
  • data capture and processing
  • interim analyses
  • choice of populations
  • handling of missing values and outliers
  • multiplicity

 

Course # 8. Non-clinical safety studies for the conduct of human clinical trials

Duration: 6 hours
Contents:
This training course will review general principles for non-clinical safety studies required to start human clinical trials. ICH guideline M3 (Non-clinical safety studies for the conduct of human clinical trials) will form the basis of the presentation.
Topics to be reviewed are:

  • general principles of safety pharmacology
  • toxicokinetic and pharmacokinetic studies
  • kinds of toxicity studies, including
    • single dose toxicity studies
    • repeated dose toxicity studies
    • local tolerance studies
    • genotoxicity studies
    • carcinogenicity studies
    • reproduction toxicity studies
  • studies required before clinical testing in pediatric populations

 

Course # 9. Investigator’s brochure

Duration: 1 hours
Contents:
This training course will describe the requirements to an Investigator’s Brochure (IB).
You will also get practical tips for how to write a good IB.

 

Course # 10. Clinical trial protocols

Duration: 2 hours
Contents:
In this training course you will learn about the requirements to a clinical trial protocol.
You will also get practical tips for how to write a good protocol.

 

Course # 11. Clinical trial application to competent authorities

Duration: 3 hours
Contents:
This training course will provide information about the European system for clinical trial applications and approvals from competent authorities.
Topics to be reviewed are:

  • Brief introduction to clinical trial directive
  • Application procedures
  • Eudract and Eudravigilance databases
  • Documentation needed for clinical trial applications
  • IMPD (Investigational Medicinal Product Dossier) – basic requirements to pharmaceutical, chemical documentation, non-clinical and clinical documentation
  • Specific information about country specific requirements (applicable countries decided based on upfront requests from course participants)

 

Course # 12. Ethical considerations and application to ethics committee

Duration: 3 hours
Contents:
This training course will provide information about the European system for clinical trial applications and approvals from ethics committees. Ethical considerations in clinical studies will be discussed.
Topics to be reviewed are:

  • Brief introduction to clinical trial directive
  • Helsinki Declaration
  • Application procedures
  • Documentation needed for clinical trial applications
  • Specific information about country specific requirements (applicable countries decided based on upfront requests from course participants)

 

Course # 13. Chemical-pharmaceutical requirements for IMP

Duration: 4 hours
Contents:
This training course will provide information about basic requirements to chemical and pharmaceutical documentation for the investigational medicinal product (IMP) to be used in clinical trials.
Topics to be reviewed are:

  • Brief introduction to GMP (Good Manufacturing Practice) in general
  • GMP Annex 13
  • IMPD (Investigational Medicinal Product Dossier) – basic requirements to pharmaceutical, chemical documentation
  • Release of IMP

 

Course # 14. Practical conduct of a clinical trial

Duration: 4 hours
Contents:
The content of this training course will be adapted to the positions and responsibilities of the audience.
An overall overview of tasks during a clinical trial will be presented with a detailed description of the responsibilities and tasks of the target audience demonstrating the practical work related to the clinical trial.

 

Course # 15. Pharmacovigilance – reporting adverse events from clinical trials

Duration: 4 hours
Contents:
In this training course the principles for pharmacovigilance in clinical trials will be reviewed.
Topics to be covered are:

  • Definitions (adverse events, adverse reactions)
  • SAE reporting and writing of SAE narratives
  • Eudravigilance database and expedited reporting of SUSARs

 

Course # 16. MedDRA – the medical dictionary for regulatory activities

Duration: 4 hours
Contents:
In this training course the basic principles of MedDRA (the medical dictionary for regulatory activities) will be reviewed. Case discussions and practical examples of the use of MedDRA will be provided.

 

Course # 17. Case report forms

Duration: 4 hours
Contents:
In this training course you will get practical tips for how to design good Case Report Forms (CRF).
Examples of structure and minimum content of CRFs will be provided.

 

Course # 18. How to critically review published articles

Duration: 4 hours
Contents:
In this training course you will learn how to critically assess the quality of a published article. Tools for such evaluations will be presented.

 

Course # 19. Writing manuscripts for publication

Duration: 4 hours
Contents:
This training course will provide practical tips for how to write a good manuscript.

 

Course # 20. Audits and inspections

Duration: 6 hours
Contents:
In this training course you will learn about the purpose of audits and inspections and how to prepare for audits and inspections. Examples of common audit findings will be presented.

 

Course # 21. Basic monitoring techniques

Duration: 6 hours
Contents:
In this training course you will learn about the responsibility of the monitor. Basic monitoring techniques, including source data verification principles will be presented.
The training course requires sufficient GCP knowledge (i.e. participation in training course no. 3 or similar course).

 

Course # 22. Clinical project management

Duration: 8 hours
Contents:
In this training course you will get practical tips and tools for how to best manage a clinical project.
Topics will include:

  • Project manuals and tools
  • Interaction with team members
  • Progress monitoring, status reporting and pro-active involvement/action plans

 

Course # 23. GCP for investigators

Duration: 4 hours
Contents:
In this training course the guidelines for Good Clinical Practice (ICH topic E6) will be reviewed with particular focus on the investigator’s responsibilities. Examples from real life and case discussions will be presented.
More extensive GCP training is provided in training course no.

 

Course # 24. GCP for study nurses and project secretaries

Duration: 4 hours
Contents:
In this training course the guidelines for Good Clinical Practice (ICH topic E6) will be reviewed with particular focus on the investigator’s and site staff’s responsibilities. Examples from real life and case discussions will be presented.
More extensive GCP training is provided in training course no. 3.

 

Course # 25. IMP management in clinical trials

Duration: 4 hours
Contents:
In this training course the practical management of investigational medicinal products (IMP) will be reviewed.
Topics to be covered are:

  • Brief introduction to Good Manufacturing Practice, annex 13
  • Labelling of IMP
  • Accountability of IMP
  • Storage of IMP

Requirements to chemical and pharmaceutical documentation are only briefly commented. For more details about such requirements cf. course no. 13.

 

Course # 26. Clinical development plan / regulatory strategies

Duration: 4 hours
Contents:
In this training course you will learn about the content and preparation of a clinical development plan.
Participation in this course requires a minimum of three years practical experience with clinical trials and/or regulatory activities. Participation in training courses 6, 8 and 10 (or similar courses) is recommended prior to participation in this course.

 

Course # 27. Master regulatory dossier

Duration: 3 hours
Contents:
In this training course you will get an overview of the content of the Common Technical Document (CTD) and the requirements as set out in Notice to Applicants.

 

Course # 28. tbc

 

Course # 29. Time management

Duration: 6 hours
Contents:
How to be efficient?
This training course will present tips for organization of your time and your tasks to make your work most efficient.

 

Course # 30. Clinical trials of medical devices

Duration: 4 hours
Contents:
In this training course you will get an introduction to relevant EU directives and regulations for clinical trials of medical devices.
EN 540 and local requirements will be presented.

 

Course # 31. Outcomes research - an introduction

Duration: 6 hours
Contents:
This training course will introduce the basic principles of outcomes research.
Topics will include:

  • Patients’ experienced outcomes of treatment
  • Measuring outcomes

 

Course # 32. Quality of life studies

Duration: 4 hours
Contents:
This training course will give an introduction to the possible definitions of quality of life (QoL) and how QoL can be measured in clinical trials.

 

Course # 33. European marketing authorisation application procedures - an introduction

Duration: 4 hours
Contents:
This training course will review the European possibilities for marketing authorisation applications (centralised procedure, decentralised procedure, mutual recognition procedure (and national procedure)).
The basic principles, differences, possibilities and restrictions of the different procedures will be presented.