Course description
The course goal is to provide you with the right skills to handle properly pharmaceutical CTD files Module 4, 5 & 2. It covers all the areas of knowledge that a person needs to understand how to review, assess, and correct Module 4, 5 & 2 of the CTD file based on ICH guidelines (ex. using JFDA & Gulf forms) with practical application, and many more. The course uses different ways of delivering knowledge like case studies, videos, exercises, and individual tests. At the completion of the course, the skills that YOU will have are practical, applicable, and implementable. You can find the course outline in the video above
What you'll learn
- Participants will be introduced to an overview of research methods using clinical and non-clinical studies in order to understand different parts odf M4 & M5 of CTD
- Participants will learn how to go through & review Module 4 for Originators. Participants will be able to understand the drug non-clinical studies requirements with examples according to the CTD guidelines
- Participants will learn how to go through & review Module 5 for Originators. Participants will be able to understand the drug clinical studies requirements with examples according to the CTD guidelines
- Participants will go through Model 2 for the clinical and nonclinical summaries and will understand what they contain and how they are written
Instructor: Dr. Samer Sowidan
- Duration: 8 Hrs. Two Days
- Time: 4.00 pm-8.00 pm
- Prerequisite for this course: None
- Language: English
- Level: Management or any one interested
- Classroom or Vitual Training
- Price $ 390
- Certificate of completion is provided
- Discount available for companies who send three or more participants
- Seats for this course: 12
- Virtual through zoom or google meet
- Classroom course at Upbeat office, hotel or at the customer premises
Registration Form
After Registration , You will be redirected to the PayPal or credit card (through PayPal gateway) payment.
