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 UK and the US

    • Suitable for sponsors, CROs and trial sites

    Program:

    • 1 full day course
    • Performed in English (translation 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)

    https://www.transcelerate-gcp-mutual-recognition.com/view-course 

    (Provider: Florian Adragna)

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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 UK and the US 

    • 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)

    https://www.transcelerate-gcp-mutual-recognition.com/view-course 

    (Provider: Florian Adragna)

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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: Good Knowledge Transfer Practice

    Goal:

    • Reduce quality issues throughout clinical trials by improving design and training quality
    1. Identify situations and tasks requiring proper knowledge transfer methodology
    2. Defining and adapt learning and document goals
    3. Identify recurrent problematic flaws in design and execution
    4. ​Design didactically sound and efficient presentations, documents and courses

    Program:

    • 1-day workshop, aimed primarily at sponsor representatives, at Project Managers and any personel performing training tasks

    • PART 1: Introduction and principles
    • PART 2: Audio-visual and printed contents
    • PART 3: Presentations & curricula

    • Various exercises using true-to-life mock study material 
    • Or working on your own material
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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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