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.

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