Advanced Regulatory Writing Course

Advanced Regulatory Writing Course

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

  • ★ ★ ★ ★ ★ 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

26 Feb 2024

EMI Starting at

₹ 9944/month

Total Program Fee

₹ 89500

Learning Period

96 Hours

Placed Learners

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Accreditations & Affiliations

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World’s #1 Upskilling & Reskilling Institute

Key Features

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10 in 1 Course

Live Classes + Projects + Internship + Certification + Placement + E-learning + Masterclass + Hackathons + Gold Membership + Entrepreneurship Mentorship

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Industry-Validated Curriculum

The curriculum is designed in a structured & coherent manner by our qualified experts to meet the requirements of the learners.

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Real-Time Projects

At the end of the course, each learner gets hands-on experience by working on 4+ real-time case studies and projects.

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Top Notch Industry Professionals

Get trained directly from domain-specific industry experts to polish your existing knowledge and skills.

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24x7 Support and Assistance

Full-time access and support to resolve your technical queries and doubts. Get Free access to the E-learning Portal and future updates.

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1 Year Gold Membership

Once enrolled at our Writing Academy, attend different batches with different trainers during the membership period without paying extra.

Upcoming Cohorts

Our Placement Stats

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Average salary hike

2100+

Access the best jobs in industry

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Maximum salary hike

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

You Get 10-In-1 Program

Two-way Live Training Course

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Hallmark Certification

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10+ Projects

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Guaranteed Internship

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Personalized Job Support

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Student Engagement & Events

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Masterclass

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E-Learning Access

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Gold Membership

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Entrepreneurship Mentorship

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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

Skills Covered

Investigator Brochure

Informed Consent Form (ICF)

Clinical Documentation

Clinical Study Protocol

Clinical Study Report

Biologics License Application (BLA)

Career Services By Henry Harvin®

Career Services
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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.

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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.

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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.

Get Ahead with Henry Harvin® Advanced Regulatory Writing Course Certification

  • 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®

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Our courses and Course Certificates are trusted by these industry leaders

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Know more about the value of this certificate in the industry

Advanced Regulatory Writing Course Training Certification Process

Counselling and Registration

Please consult with our counselors to check your eligibility and the suitable batch, and then Register for the Advanced Regulatory Writing Course

Attend the Training

Attend 96 Hours of sessions and get completion certification from Henry Harvin® Writing Academy

Deliver Assigned Projects

Gather experience with real-world assignments and practical projects to upgrade your existing skills. Deliver these mini-projects to be eligible for the Henry Harvin® Course.

Earn Certification

Post-completion of the course, earn a Henry Harvin® Certificate. You can post it on social media, get it framed & increase your value in the industry

Know more about the value of this certificate in the industry

Related Jobs

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

Know the complete offerings of our Advanced Regulatory Writing Course

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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.

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Why Us?

Certified & Experienced Instructors

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Gold Membership & Post Training Followups

Tailor Made Training

Flexible Schedule

Access to the Recorded Sessions

10 in 1 Program

Masterclasses By Henry Harvin®️

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