Florian L. Adragna, M.Sc.

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)

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)

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)

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

Goal:

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

Program:

• 2 hours presentation and group discussion

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

Goal:

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

Program:

• 1-hour presentation, possibility of group work after

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