What is Advanced Regulatory Writing Course?

The advanced regulatory writing course is designed to learn about Developing an Investigator Brochure, Creating an Informed Consent Form (ICF), Writing a Clinical Study Report (CSR), and many more

Who are the trainers, and how do they get selected by Henry Harvin®?

Our trainers are Certified Professional Trainers with more than 15 years of experience in training and working professionally in the field. Each has to appear through a rigorous selection process that includes profile screening, technical evaluation, and live training demonstration before they are certified to train for us. We also ensure that only trainers with a high alumni rating continue to train for us.

Does Henry Harvin® offer Corporate Training?

We are happy to inform you that Henry Harvin® has exclusive corporate training sessions with experts on board.

Can I take a break from the classes during the course?

Well, there is no such option of taking a break from the classes in an ongoing course. Instead, professionals can change their batch from instructor-led to self-paced training classes.

Can I change my learning mode from self-paced to instructor-led training programs?

Henry Harvin® offers an easy and hassle-free process to convert the mode of learning.

Does Henry Harvin® offer Corporate Training?

We are happy to inform you that Henry Harvin® has exclusive corporate training sessions with experts on board.

Who are the trainers, and how do they get selected by Henry Harvin®?

Our trainers are Certified Professional Trainers with more than 15 years of experience in training and working professionally in the field. Each has to appear through a rigorous selection process that includes profile screening, technical evaluation, and live training demonstration before they are certified to train for us. We also ensure that only trainers with a high alumni rating continue to train for us.

Can I take a break from the classes during the course?

Well, there is no such option of taking a break from the classes in an ongoing course. Instead, professionals can change their batch from instructor-led to self-paced training classes.

How many learning modules are there in this course?

There are 11 learning modules with 5 case studies for a clear understanding of the topics.

Can I change my learning mode from self-paced to instructor-led training programs?

Henry Harvin® offers an easy and hassle-free process to convert the mode of learning.

Advanced Regulatory Writing Course

Q: Does Henry Harvin® offer Corporate Training?

We are happy to inform you that Henry Harvin&reg; has exclusive corporate training sessions with experts on board.

Q: Can I change my learning mode from self-paced to instructor-led training programs?

Henry Harvin&reg; offers an easy and hassle-free process to convert the mode of learning.

Q: Does Henry Harvin® offer Corporate Training?

We are happy to inform you that Henry Harvin&reg; has exclusive corporate training sessions with experts on board.

Q: Can I change my learning mode from self-paced to instructor-led training programs?

Henry Harvin&reg; offers an easy and hassle-free process to convert the mode of learning.

Advanced Regulatory Writing Course

Henry Harvin® Ranks in Top 30 most Trusted Companies by Insight Success

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★ ★ ★ ★ ★ 4.8/5 Ratings
1.1 Million Learners
1455 Learner’s Rating
81% Report Career Benefits

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

Starts In 1 day

29 Apr 2024

Learning Period

96 Hours

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Placed Learners

FAQs

Accreditations & Affiliations

There's a reason that 95% of our alumni undertake 3+ courses as a minimum with Henry Harvin®

Know the complete offerings of our Advanced Regulatory Writing Course

Key Highlights

10 in 1 Course

Industry-Validated Curriculum

Real-Time Projects

Top Notch Industry Professionals

24x7 Support and Assistance

1 Year Gold Membership

Upcoming Cohorts

VIEW SCHEDULE ENROLL NOW

Our Placement Stats

95%

Average salary hike

2100+

Access the best jobs in industry

147%

Maximum salary hike

Access the best jobs in the industry

You Get 10-In-1 Program

Two-way Live Training Course

Two-way Live Online Interactive Classroom Sessions

Certification

Distinguish your profile with global credentials and showcase expertise with our Hallmark Completion certificate

Projects

Facility to undergo various projects along with the course.

Guaranteed Internship

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

Placement

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

Student Engagement & Events

Free Access to #AskHenry Hackathons and Competitions & many other facilities from Henry Harvin®

Masterclass

Access to 52+ Masterclass Sessions for essential soft skill development

Membership

Get Free Gold Membership of Henry Harvin®

E-Learning Access

Free access to the E-learning Portal and future updates. Get access to PPTs, Projects, Quizzes, self-paced Video-based learning, a question bank, a library, practice tests, final assessment, a forum, and doubt sessions.

Entrepreneurship Mentorship

Mentorship from Young Successful Entrepreneurs to set up a sustainable & scalable Business from scratch at both Freelance and entrepreneur levels

About the Advanced Regulatory Writing Course

Advanced Regulatory Writing Course

The advanced regulatory writing course offers lessons on designing a clinical protocol, the Purpose and key components of the protocol, Creating an Informed Consent Form (ICF), and many more.

10 in 1 Course

Training: 96 Hours of Two-Way Live Online Interactive Sessions
Projects: Facility to undergo projects in Creating an Informed Consent Form (ICF) and more
Internship: Get Internship Support to gain experiential learning
Certification: Get course completion Certification of Advanced Regulatory Writing Henry Harvin® Govt of India recognized and award-winning Institute, and showcase expertise
Placement: 100% Placement Support for 1 Year post successful completion of the course
E-Learning: Free access to E-learning Portal and future updates
Masterclass: Access to 52+ Masterclass Sessions for essential soft skill development
Hackathons: Free Access to #AskHenry Hackathons and Competitions
Membership: 1-Year Gold Membership of Henry Harvin® Writing Academy
Entrepreneurship Mentorship: Mentorship from Young Successful Entrepreneurs to set up a sustainable & scalable Business from scratch at both Freelance and entrepreneur level

Trainers at Henry Harvin®

Most respected industry experts with 15+ years of working experience and recognized by numerous organizations over the years for their work.
They have delivered 400+ keynote classes for the Advanced Regulatory Writing Course
Have delivered 450+ lectures and are currently empaneled as domain experts with Henry Harvin® Writing Academy

Alumni Status

Become a part of the Elite Writing Academy of Henry Harvin® and join the 4,60,000+ large Alumni Network Worldwide.

Gold Membership Benefits

Avail 1-Year Gold Membership of Henry Harvin® Writing Academy that includes E-Learning Access through recorded Videos, Games, Projects, CPDSPe Studies
Access to Masterclass Sessions
Earn the Prestigious Henry Harvin®️ Alumni Status and become one of the reputed 4,60,000+ Alumni globally
Guaranteed Internship with Henry Harvin®️ or partner firms
Weekly 10+ job opportunities offered.
Experience Industry Projects during the training

Learning Benefits

Purpose and key components of the ICF.
Learn best practices for writing an ICF, including procedures, risks, and benefits.
Learn about writing a Clinical Study Report (CSR)
Work on common issues and challenges in CSR development
Preparing Regulatory Submissions
Work on the best practices for preparing regulatory submissions, including adherence to regulatory guidelines.

Know the complete offerings of our Advanced Regulatory Writing Course

Advanced Regulatory Writing Course Curriculum

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.
Complimentary Module 1: Soft Skills Development
- Business Communication
- Preparation for the Interview
- Presentation Skills
Complimentary Module2: Resume Writing
- Resume Writing

Know the complete offerings of our Post Graduate Program in Advanced Regulatory Writing Course

Book a Live Class, For Free!

By continuing you agree to Henry Harvin® Terms & conditions and Privacy Policy

Upcoming Cohort

Henry Harvin® Ranks #1

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Starts in 1 day. 29 Apr 2024

Skills Covered

Investigator Brochure

Informed Consent Form (ICF)

Clinical Documentation

Clinical Study Protocol

Clinical Study Report

Biologics License Application (BLA)

Certifications

Get Ahead with Henry Harvin® Advanced Regulatory Writing Course Certification

What you'll Learn in this course

Earn your Certification

Our course is exhaustive and this Certification is proof that you have taken a giant leap in mastering the domain

Differentiate yourself with Henry Harvin®

The practical knowledge and actionable skillset you've gained working on projects, simulations, and case studies will set you ahead of the competition

Share Your Achievement

Talk about it on LinkedIn, WhatsApp, Instagram, Facebook, and Twitter, boost your resume, or frame it - tell your friends and colleagues about it.

Training Certification

Get an Advanced Regulatory Writing Course Completion Certification from Henry Harvin®

Our courses and Course Certificates are trusted by these industry leaders

Know more about the value of this certificate in the industry

Career Services By Henry Harvin®

Placement Drives

We are dedicated to supporting our students throughout their career journey. Join us, and let's embark on a journey towards a successful and fulfilling career together.

Premium access to Henry Harvin® Job portal

Exclusive access to our dedicated job portal and apply for jobs. More than 2100+ hiring partners’ including top start–ups and product companies hiring our learners. Mentored support on job search and relevant jobs for your career growth.

Personalized Job Consulting

Share what kind of job you are looking for and we will provide you with verified job openings that match your requirement.

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FAQs

What is Advanced Regulatory Writing Course?

The advanced regulatory writing course is designed to learn about Developing an Investigator Brochure, Creating an Informed Consent Form (ICF), Writing a Clinical Study Report (CSR), and many more
Who are the trainers, and how do they get selected by Henry Harvin®?

Our trainers are Certified Professional Trainers with more than 15 years of experience in training and working professionally in the field. Each has to appear through a rigorous selection process that includes profile screening, technical evaluation, and live training demonstration before they are certified to train for us. We also ensure that only trainers with a high alumni rating continue to train for us.
Does Henry Harvin® offer Corporate Training?

We are happy to inform you that Henry Harvin® has exclusive corporate training sessions with experts on board.
Can I take a break from the classes during the course?

Well, there is no such option of taking a break from the classes in an ongoing course. Instead, professionals can change their batch from instructor-led to self-paced training classes.
Can I change my learning mode from self-paced to instructor-led training programs?

Henry Harvin® offers an easy and hassle-free process to convert the mode of learning.

Who We Are?

Henry Harvin®️ ranks amongst the Top 500 Global Edtech Companies with 4,60,000+ Alumni, 900+ B2B Clients, 500+ Award Winning Trainers, and 1200+ Courses.