Name: Introduction To Advanced Regulatory Writing Course in Washington | Henry Harvin
Uploaded: 2023-12-01 21:27:55
Description: Advanced Regulatory Writing by Henry Harvin® offers exclusive sessions on clinical trial documentation, clinical study protocol, and many more | Learn about the importance of clinical trial documentation and the Role of regulatory agencies in reviewing | Be in the marketplace to grab high-paying job opportunities

Module 1: Introduction to Clinical Trial Documentation
In this module, a professional will learn about Clinical trial documentation
- Importance of clinical trial documentation in ensuring regulatory compliance and patient safety.
- Overview of the types of documentation required for clinical trials.
- Role of regulatory agencies in reviewing and approving clinical trial documents.
Module 2: Designing a Clinical Study Protocol
In this module, a professional will learn about Clinical study protocol
- Purpose and key components of the protocol.
- Best practices for designing a protocol, including study objectives and methods.
- Common issues and challenges in protocol development.
Module 3: Developing an Investigator Brochure
In this module, a professional will learn about developing an investigator brochure
- Purpose and key components of the brochure.
- Best practices for writing an investigator brochure, including drug pharmacology, pharmacokinetics, and safety data.
- Common issues and challenges in investigator brochure development.
Module 4: Creating an Informed Consent Form (ICF)
In this module, a professional will learn about creating an informed consent form (ICF)
- Purpose and key components of the ICF.
- Best practices for writing an ICF, including procedures, risks, and benefits.
- Common issues and challenges in ICF development.
Module 5: Writing a Clinical Study Report (CSR)
In this module, a professional will learn about Writing a Clinical Study Report (CSR)
- Purpose and key components of the CSR.
- Best practices for writing a CSR, including data on safety and efficacy.
- Common issues and challenges in CSR development
Module 6: Preparing Regulatory Submissions
In this module, a professional will learn about common issues and challenges in regulatory submission preparation
- Purpose and key components of regulatory submissions, including the New Drug Application (NDA) or Biologics License Application (BLA).
- Best practices for preparing regulatory submissions, including adherence to regulatory guidelines.
- Common issues and challenges in regulatory submission preparation.
Module 7: Developing a Patient Information Leaflet (PIL)
In this module, a professional will learn about the purpose and key components of the PIL
- Purpose and key components of the PIL.
- Best practices for writing a PIL, including drug information, dosage, and potential side effects.
- Common issues and challenges in PIL development.
Module 8: Complimentary Module 1: Soft Skills Development
- Business Communication
- Preparation for the Interview
- Presentation Skills
Module 9: Complimentary Module2: Resume Writing
- Resume Writing

Advanced Regulatory Writing Course in Washington

11 Nov 2024

96 Hours

11 Nov 2024

96 Hours

Book a Live Class, For Free!

Accreditations & Affiliations

Know the complete offerings of our Advanced Regulatory Writing Course in Washington

Key Highlights

96 Hours of Instructor-Led Sessions

32 Hours of Live Interactive Doubt Solving Sessions

16 Hours of Live Master Sessions by Industry Experts

192 Hours of Self-Paced Learning

Job-Ready Portfolio of 10 Capstone Projects

24 Auto-Graded Assessments

20+ Industry Case Studies

144 Guided Hands-On Exercises

10+ Assignments and Mini Projects

2 Mock Interviews and 2 Hackathons

Get 1-Year Gold Membership of Henry Harvin® School of Writing Academy

Get a guaranteed Internship with Henry Harvin® and in top MNCs like J.P. Morgan, Accenture & many more via Forage

Get 3 in 1 Placement support through Placement Drives, Premium access to Job portal & Personalized Job Consulting

6 Hours of Mentorship by Industry Experts

Earn Certification of Course from Henry Harvin®, Govt of India recognized & Award-Winning Institute and NSDC Certification

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Access the best jobs in the industry

You Get 10-In-1 Program

About the Advanced Regulatory Writing Course in Washington

Advanced Regulatory Writing Course

10 in 1 Course

Trainers at Henry Harvin®

Alumni Status

Gold Membership Benefits

Learning Benefits

Curriculum For Advanced Regulatory Writing Course in Washington

Module 1: Introduction to Clinical Trial Documentation

Module 2: Designing a Clinical Study Protocol

Module 3: Developing an Investigator Brochure

Module 4: Creating an Informed Consent Form (ICF)

Module 5: Writing a Clinical Study Report (CSR)

Module 6: Preparing Regulatory Submissions

Module 7: Developing a Patient Information Leaflet (PIL)

Module 8: Complimentary Module 1: Soft Skills Development

Module 9: Complimentary Module2: Resume Writing

Admission Closes On 11 Nov 2024

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Starts in 2 day. 11 Nov 2024

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