Workshops

Investigational Product

Duration: 0.5 day
Level: Proficiency

• Based on ICH GCP, GMP and EU Directives this workshop will explain the path of IP through the clinical study and obligations of responsible parties, using a series of specially selected interactive exercises.
• Combination with other workshops (e.g. Source Data Verification, Monitoring reports) is recommended, if aimed for the same group of participants.

The Workshop is designed for organisations wishing to train a group of employees or investigational site staff at a location of their choice.

 

Good Manufacturing Practice

Duration: 0.5 day
Level: Proficiency

• This workshop will provide the clear understanding of ICH GMP requirements to Clinical Research professionals as well as investigators and other investigational site staff delegated to perform IP related activities.
• Special attention will be given to Annex13 section of ICH GMP guidelines. The objectives are focused on answers to "who", "when", "why" and "how" questions regarding packaging, shipping, storage and handling of IP.
• Combination with other workshops (e.g. Investigational Product, GCP Filing) is recommended, if aimed for the same group of participants.

The Workshop is designed for organisations wishing to train a group of employees or investigational site staff at a location of their choice.

 

Source Data Verification

Duration: 0.5 day
Level: Proficiency

• Source Data Verification workshop will guide you through practical aspects of SDV topic, that includes the difference between source data and source documents, types of source documents, requirements for the maintenance, possible discrepancies, tips for the verification and many others.
• Combination with other workshops (e.g. Investigational Product, Monitoring reports) is recommended, if aimed for the same group of participants.

The Workshop is designed for organisations wishing to train a group of employees at a location of their choice.

 

Informed Consent

Duration: 0.5 day
Level: Proficiency

• This workshop will provide the understanding of the Informed consent as an important process for the potential subject, for the investigator and for the clinical monitor.
• During this workshop we will review IC process requirements through interactive exercises with an objective to implement these efficiently into the Clinical Research practice.
• Combination with other workshops (e.g. Monitoring reports, Source Data Verification, GCP Filing) is recommended, if aimed for the same group of participants.

The Workshop is designed for organisations wishing to train a group of employees or investigational site staff at a location of their choice.

 

Monitoring Reports

Duration: 0.5 day
Level: Proficiency

• Monitoring report is an essence of what is happening at the site and one of the most important documents created by a Clinical Research monitor and reviewed by responsible personnel for completeness, triggers and compliance.
• This workshop will equip the participant with knowledge of general requirements as well as best practices of proper writing and review of the report, including the types of monitoring reports, their expected contents, stylistics and design.
• Combination with other workshops (e.g. investigational product, Informed Consent, Source Data Verification) is recommended, if aimed for the same group of participants.

The Workshop is designed for organisations wishing to train a group of employees at a location of their choice.

 

Accompanied Site Visit for Line Managers

Duration: 0.5 day
Level: Advanced

• Accompanied Site Visits are a good practice tool supporting clinical monitors in their professional growth. The aim of this workshop is to equip your Line Managers with skills and practical tips on how to manage the ASV process and how to lead their teams of monitors towards their professional growth.
• After this workshop your team of Line Mangers will be able to deliver a consistent support to their teams and contribute to the growth of your organization.
• Combination with ‘Becoming a First Line Clinical Manager’ workshop is recommended for newly assigned Line Managers.

The Workshop is designed for organisations wishing to train a group of clinical Line Managers at a location of their choice.

 

Becoming a First Line Clinical Manager

Duration: 1 day
Level: Advanced

• Have you become responsible for effectiveness and productivity of your own team?
• During our workshop you will learn how to manage people in context of business results and understand why engagement influences productivity.
• You will understand the complexity of your new role and practice in safe environment the basic people management skills.

This Workshop is designed for organisations wishing to train a group of newly assigned First Line Managers at a location of their choice.

 

GCP Refresher

Duration: 0.5 day
Level: Advanced

• Are you experienced Clinical Research professionals or Investigational site teams discovering advanced level of GCP related challenges?
• Maybe it is a good time to refresh your knowledge of GCP in a series of selected exercises and case studies to deeper your sense for GCP solutions and prevent GCP automatisms that are not the most effective ones.

The Workshop is designed for organisations and Investigational sites wishing to refresh a group of employees or Investigational site teams in GCP at a location of their choice.

 

GCP Filing

Duration: 0.5 day
Level: Proficiency

• GCP filing workshop is ready to unlock the world of properly filed documents by providing the participant with the clear and practical live interaction full of exercises, references to ICH GCP, working with the lists of essential documents. GCP filing will become understandable and easy-to-do task for CR professionals so as for Investigational Site staff thanks to the systematic approach of this workshop.
• Combination with other workshops (e.g. Monitoring reports, Informed Consent) is recommended, if aimed for the same group of participants.

The Workshop is designed for organisations wishing to train a group of employees or investigational site staff at a location of their choice.