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Why You Need to Take This Training Course?
Why You Need to Take This Training Course?
This Course will Provide YOU with:
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Enhanced Regulatory Compliance:
- Completing a course on CTD preparation and review ensures that you are well-versed in regulatory requirements and guidelines (e.g. FDA, EMEA, ICH).
- This knowledge helps pharmaceutical professionals compile comprehensive and compliant dossiers, reducing the risk of regulatory issues, delays, or rejections.
- By understanding the intricacies of CTD structure, content, and formatting, you can ensure that submissions align with regulatory expectations, increasing the likelihood of approvals and market access for new drugs.
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Improved Efficiency and Productivity:
- Courses on CTD preparation and review often cover best practices and tools for organizing, managing, and assembling regulatory submissions.
- Learning how to streamline the documentation process and utilize templates can significantly enhance efficiency.
- Well-structured and compliant CTD submissions can reduce the time and effort required for regulatory approval, ultimately accelerating the drug development and marketing process.
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Career Advancement Opportunities:
- Completing a CTD course provides valuable expertise that is in demand in the pharmaceutical industry.
- Professionals with skills in CTD preparation and review are often sought after for regulatory affairs positions within pharmaceutical companies, contract research organizations (CROs), and regulatory consulting firms.
- This specialized knowledge can open doors to higher-paying roles and career advancement opportunities in regulatory affairs, quality assurance, and related fields within the pharmaceutical sector.
What you'll learn
- To Teach Participants how to:
- Prepare the different sections of the CTD (Module 1, Module 2 & Module 3) file, including the administrative section, the quality section, and the summary of the quality section
- Select the appropriate data to include in each module (Module 1, Module 2 & Module 3) of the CTD file.
- Format and submit the CTD file in accordance with regulatory requirements.
- To develop participants’ skills in:
- Reviewing CTD (Module 1, Module 2 & Module 3) files for completeness, accuracy, and compliance with regulatory requirements.
- Identifying and addressing potential deficiencies in CTD (Module 1, Module 2 & Module 3) files.
- Communicating effectively with regulatory authorities about CTD (Module 1, Module 2 & Module 3) files.
Instructor: Dr. Samer Sowidan
- Duration: 16 Hrs. Two Days
- Time: 9.00 am-5.00 pm
- Prerequisite for this course: None
- Language: English
- Level: Management or any one interested
- Classroom or Vitual Training
- Price US $ 495
- Certificate of completion is provided
- Discount available for companies who send three or more participants
- Seats for this course: 12
- Virtual through google meet
- Classroom course at Upbeat office, hotel or at the customer premises
Registration Form
After Registeration , You will be redirected to the payment page
