Name: Introduction To Advanced Regulatory Writing Course in Indianapolis | 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 Indianapolis

23 Dec 2024

Book a Live Class, For Free!

Accreditations & Affiliations

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

About Advanced Regulatory Writing Course in Indianapolis

Advanced Regulatory Writing Course

10 in 1 Course

Trainers at Henry Harvin®

Alumni Status

Gold Membership Benefits

Learning Benefits

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

Our Placement Stats

Access the best jobs in the industry

You Get 10-In-1 Program

Curriculum For Advanced Regulatory Writing Course in Indianapolis

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 23 Dec 2024

Upcoming Cohort

Henry Harvin® Ranks #1

Starts in 5 day. 23 Dec 2024

Upcoming Cohorts

Skills Covered

Certifications

Get Ahead with Henry Harvin® Advanced Regulatory Writing Course in Indianapolis Certification

What you'll Learn in this course

Earn your Certification

Differentiate yourself with Henry Harvin®

Share Your Achievement

Training Certification

Our courses and Course Certificates are trusted by these industry leaders

Career Services By Henry Harvin®

Placement Drives

Premium access to Henry Harvin® Job portal

Personalized Job Consulting

Popular Programs

Content Writing Course

Medical Writing Course

Instructional Design

Creative Writing Course

Copywriting Course

Articulate Storyline 360 Course

Pharmacovigilance Course

Regulatory Writing Course

Adobe Captivate Course

Madcap Flare Course

Oxygen XML Tool Training

Research Writing Course

Advance Content Writing & ChatGPT Course

Email writing

Academic Writing Course

Basic Certification Course in Instructional Design by E&ICT Academy, IIT Guwahati

Art of Negotiation Course

Certificate Course in Feature Writing

Cross Cultural Sensitivity Course

Certificate Course in Script Writing