Florian L. Adragna, M.Sc.


CRA & GCP Auditor - Berlin

Courses

In addition to my role as a Clinical Research Associate, I have been a certified and active instructor since 2008.


Below, you will find a list of the presentations and courses I have authored and designed. These materials cater to a wide range of audiences and cover various topics.


For further information, please feel free to reach out to me via my contact page.


Clinical research

  • Basics of Good Clinical Practice (GCP) - Human Medicines

    Goal:

    • Introduction to the ground principles and international standards in ethical clinical research with Human Medicines

    • Course for Germany (France, Austria, The Netherlands, the UK and US pending)

    • Suitable for sponsors, CROs and trials sites

    Program:

    • 1 full day course
    • Performed in English (translation to German available upon request)
    • Made in consideration of the criteria for TransCelerate Mutual Recognition
    • Made in consideration of the programm from the German Bundesärztekammer

    1. Ethics, methodology and regulations (2 UE / Lesson Units)
    2. Planning and preparation (0,75 UE / Lesson Unit)
    3. ​Implementation of the clinical study (0,75 UE / Lesson Unit)
    4. Study Course and documentation (1,5 UE / Lesson Units)
    5. Adverse Events and Safety (2 UE / Lesson Units)
    6. Completion of the clinical trial (1 UE / Lesson Unit)
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  • Basics of Good Clinical Practice (GCP) - Medical Devices

    Goal:

    • Introduction to the ground principles and international standards in ethical clinical research with Medical Devices

    • Course for Germany (France, Austria, The Netherlands, the UK and US pending)

    • Suitable for sponsors, CROs and trials sites

    • Emphasizes the key differences with trials involving human medicines

    • ISO 14155 and ICH E6

    Program:

    • 1 full day course
    • Performed in English (translation to German available upon request)
    • Made in consideration of the criteria for TransCelerate Mutual Recognition
    • Made in consideration of the programm from the German Bundesärztekammer

    1. Ethics, methodology and regulations (2 UE / Lesson Units)
    2. Planning and preparation (0,75 UE / Lesson Unit)
    3. ​Implementation of the clinical study (0,75 UE / Lesson Unit)
    4. Study Course and documentation (1,5 UE / Lesson Units)
    5. Adverse Events and Safety (2 UE / Lesson Units)
    6. Completion of the clinical trial (1 UE / Lesson Unit)
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  • Complementary basics of GCP - Medical Devices

    Goal:

    • Complementary course to the ground principles and international standards in ethical clinical research for active personnel in possession of a so called "GCP certificate" and who need to perform clinical investigations with Medical Devices

    • Course for Germany (France, Austria, The Netherlands, the UK and US pending)

    • Suitable for sponsors, CROs and trials sites

    • Emphasizes the key differences with trials involving human medicines

    • ISO 14155 and ICH E6

    Program:

    • Half day course
    • Performed in English (translation to German available upon request)
    • Made in consideration of the programm from the German Bundesärztekammer

    1. Ethics, methodology and regulations (1 UE / Lesson Unit)
    2. ​Implementation of the clinical study (0,75 UE / Lesson Unit)
    3. Study Course and documentation (0,25 UE / Lesson Units)
    4. Adverse Events and Safety (2 UE / Lesson Units)
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  • Efficacy Guidance: Qualification and Initiation Visits

    Goal:

    • Reduce quality issues during clinical studies by improving initial trainings
    1. Defining learning goals
    2. Refining qualification and initiation visits programs
    3. ​Improve study documents' layout
    4. Create and perform didactically sound presentations

    Program:

    • 1-day workshop, aimed primarily at sponsor representatives and at Project Managers
    • Introduction to the didactic method
    • Defining adequate learning goals
    • Various exercises to improve layout of documents and presentations
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  • Difficult site situations

    Goal:

    • how to “handle difficult site situations” and avoid a breakdown in communication

    Program:

    • 2 hours presentation and group discussion
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For general public

  • Basics of didactics

    Goal:

    • Improve the quality of your trainings and training materials
    1. Defining learning goals
    2. Refining programs
    3. ​Improve study documents' layout
    4. Create and perform didactically sound presentations

    Program:

    • 1-day workshop
    • Introduction to the didactic method
    • Defining adequate learning goals
    • Various exercises to improve layout of documents and presentations
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  • Open Source Software and free resources

    Goal:

    • how to learn new skills, for free, without using proprietary software

    Program:

    • 1-hour presentation, possibility of group work after
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First Aid and Safety

  • First Aid and Safety in international companies

    Goal:

    • Discuss challenges for safety in international environments 
    • Discuss specific risks
    • Discuss participants' educational background in First Aid and how they may differ from local methods

    Program:

    • Open discussion
    • Discussion of potential scenarios
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