Online Course 
Medical Device Certificate Elective 
Pharmaceutical Certificate Elective Intermediate Medical Writing: Investigational Applications [6.0 RAC]
Member: $610.00 Nonmember: $845.00![Intermediate Medical Writing: Investigational Applications [6.0 RAC]](https://my.raps.org:443/images/8af20560-0907-456b-966f-c642b35a1645.img?resize=yes)
Regulatory and medical writing is an integral part of the product development and approval process and plays a crucial role in assuring that submissions for new investigational products are well organized, accurate and reviewer-friendly.
This course provides an overview of the variety of investigational applications prepared by regulatory and medical writers for both drugs/biologics and medical devices. Key investigational submissions covered include region-specific applications for drugs/biologics such as the Investigational New Drug Application (IND), Canadian Clinical Trial Application (CTA) and Investigational Medicinal Product Dossier (IMPD), as well as those required for investigational devices such as the Investigational Device Exemption (IDE), European CTA and Investigational Testing Authorization (ITA). Participants will be introduced to the components of each of these application types and learn techniques for improving document quality in order to advance your career as a regulatory and medical writer.
At a Glance
- Target Audience: This course is intended for Professionals with one to three years’ experience in medical writing and those who need a basic introduction to the regulatory documents discussed.
- Learning Level: Basic
- Total Length of Course: 6 Hours
- RAC Points: 6
Learning Objectives
Upon completion of this course, participants should be able to:
- Determine the most appropriate IND required for a clinical trial involving an investigational new drug/biologic in the US and discuss the regulatory process for IND submission, review and update.
- Determine when an IDE application is required for a clinical trial involving an investigational medical device in the US, describe the structure and content needed to prepare an IDE submission and discuss the regulatory requirements in the case of changes to investigational device or protocol during the conduct of an IDE study
- Determine when a CTA is required for a clinical trial involving an investigational new drug/biologic in Canada and discuss the regulatory process for CTA and CTA-A submission and review, including the value of Pre-CTA consultation meeting(s)
- Determine when an ITA application is required for a clinical trial involving an investigational medical device in Canada and describe the structure and content needed to prepare an ITA submission.
- Discuss when and how to approach Health Canada for pre-submission consultation prior to submitting an ITA and determine regulatory requirements in the case of changes to investigational device or protocol during the conduct of an ITA study.
- Explain and summarize the data requirements for writing the IMPD.
- Outline and describe the core documentation required to submit a clinical trial application (CTA) in Europe.
Lesson Titles
- Lesson 1: Investigational New Drug Application (IND)
- Lesson 2: Investigational Device Exemptions (IDE)
- Lesson 3:Canadian Clinical Trial Application
- Lesson 4: Investigational Testing Authorization (ITA)
- Lesson 5: Investigational Medicinal Product Dossier (IMPD)
- Lesson 6: European Clinical Trial Application
Enrollment Period: 12 months
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