Technical File Preparation Workshop Road Map
Goal: To complete the technical file preparation process effectively and efficiently.
Target Audience: All stakeholders involved in preparing the technical file (regulatory experts, clinical research experts, product engineers, quality control experts, etc.).
01
Preparation Phase
(1 Week)
The purpose and objectives of the workshop are clarified.
The target audience is determined and their needs are analyzed.
Speakers and presentation topics are determined.
Workshop program and materials are prepared.
Registration and participation procedures are determined.
02
Workshop Phase (1 Day)
Workshop presentations and interactive sessions are held.
Practical application opportunities are provided through group studies and case studies.
Question-answer and discussion sessions are held.
Feedback is received from participants.
03
Post Phase (1 Week)
Workshop results and recommendations are compiled in a report.
Reports and presentation materials are sent to the participants.
Necessary follow-ups and actions are determined.
Topics to be covered in the workshop:
Content and format of the technical file
Regulatory requirements
Evaluation of clinical trial data
Product safety and risk assessment
Quality control and production processes
File evaluation process and possible problems
International standards and compliance
Benefits of the Workshop:
Better understanding of the technical file preparation process
Increasing communication and coordination among stakeholders
Sharing knowledge and experience
Ensuring regulatory compliance
Reducing file preparation time and cost
Workshop Materials:
presentation slides
Case studies
Event program
Participant list
Feedback forms
For the Workshop to be Successful:
Active participation of the target audience
Open and transparent communication
Practical application possibility
Taking feedback into account
I hope this roadmap helps you organize your technical file preparation workshop.
