InstructorRoyed Training
TypeOnline Course
Price$390 USD / 18500 INR.
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pharmaceutical regulatory affairs

Introduction

Course Type

Course Duration

Eligibility

Certification

Features

Related Courses

About RA

pharmaceutical regulatory affairs course

This online pharmaceutical regulatory affairs course provides understanding of pharmaceutical regulation, pharmaceutical registration process.

Advance Certification is designed to create effective Regulatory Affairs Manager for Pharmaceutical Industry. Pharmaceutical Regulatory Affairs training gives practical knowledge and real life job simulation. Course focus on how regulatory professionals work in company and understanding of key responsibilities and job functions.

In this online self-paced modules, participant will be understanding about the drug development to commercialization process in detail. Therefore, it is easy and convenient to access. Course can be accessed 24×7, across anywhere.

The course trains the candidate on stages of drug discovery and development, investigational new drug application, new drug application, handling of different phases of clinical trial, generic drug approval process, Abbreviated new drug applications will be covered in phased manner for easy understanding. Moreover, Course covers fundamental to advance learning on drug development, regulation, registration and strategic management process. Above all, this course features regulatory affairs strategic planning.

Who should attend this course? 

  • Those who are in pharmaceutical regulatory affairs and related department.
  • Professionals from drug discovery development.
  • Anyone requiring an overview of drug regulatory affairs.
  • Fresher or beginners, Those who want to make a career in drug regulatory department.

Course Code: RYD-001

Title: Advanced Certificate Course in Pharmaceutical Regulatory Affairs

Online distance learning course. So, course can be accessed online across anywhere 24×7.

1 Year

Any body who wants to acquire drug regulatory affairs competency should attend the course.

Certificate will be provided at the end of the successful completion of the course

  • Pharmaceutical Regulatory Affairs Course provides in-depth orientation to job related practical aspects of the pharmaceutical regulatory managers.
  • In fact, the course focus on inculcating the decision making skill of the course participants on regulatory strategic planning.
  • Advance training on drug registration requirements for various regulatory bodies.
  • Access to Case Studies to learn about the drug registration steps.

Career in Pharmaceutical Regulatory Affairs

A career in Pharmaceutical Regulatory Affairs is very challenging, but highly rewarding. In fact, it opens up lot of opportunities for professionals. But the regulatory job covers a variety of disciplines. For instance, regulatory professional involved involved in regulatory submission, compliance, clinical trials, quality assurance, drug safety, pharmacovigilance. Hence, they should have comprehensive knowledge on various topics. For example, drug discovery development process, regulatory authorization process, quality assurance, quality control, formulation, etc. More the knowledge, it will be more beneficial. In turn, it help them to reach a greater height in organization hierarchy. pharmaceutical regulatory affairs course

The Pharma and biopharma industry is growing at a rapid pace. But there is a rising concern over the safety and efficacy. Major objective of the regulatory department to maintain safety and efficacy of the drugs and biopharmaceutical molecules. And to maintain safety and efficacy in pharmaceutical and biopharmaceutical products, regulatory agencies all over the world are imposing number of regulation. These regulations are evolving and changing every other day. Hence, regulatory professionals must have thorough knowledge about the updated regulations. Sound regulatory knowledge helps them to take strategic decision effectively.  Therefore, this has resulted in creation of regulatory department with certified regulatory affairs professionals. Above all, it help companies to meet these requirements with ease.

About regulatory affairs job>> Learn here

Section 1Drug Discovery Development & Regulations
Lecture 1 Download Course Module & Course Introduction
Lecture 2R&D Process - Introduction to drug discovery
Lecture 3Investigational New Drug Application (INDA)
Lecture 4New Drug Application (NDA) 
Lecture 5Basic concept and understanding of the Generic Drug 
Lecture 6Abbreviated New Drug Application (ANDA) 
Lecture 7USFDA Expedited Program
Lecture 8505(j) ANDA, 505(b)(2) NDA, 505(b)(1) NDA
Lecture 9Authorized Generics: Key Understanding
Lecture 10Exploratory IND Vs. Traditional IND
Lecture 11Patent & Exclusivity - Strategic Understanding | Patent Restoration| Orphan Drug Exclusivity (ODE) | NCE & NCI Exclusivity | GAIN Exclusivity | Pediatric Exclusivity | 180 days exclusivity
Lecture 12Orphan Drug Designation 
Lecture 13Advance Learning on 505B2 Pathway
Lecture 14Chemistry, Manufacturing & Controls 
Lecture 15Review of Drug Discovery Development 
Section 2Clinical Trial & Related Learning
Lecture 16Understanding on Clinical Trials  and Clinical Research 
Lecture 17Clinical Trial Protocol Writing
Lecture 18Ethics in Clinical Research
Lecture 19FDA Forms and How to fill the resources
Lecture 20Strategic Discussion: PreIND, EOP1, EOP2 - What to expect
Section 3Advance Strategic Management
Lecture 21Regulatory Strategies in different phases of Clinical Trial
Lecture 22Advance study on Para IV Filing
Lecture 23Para IV Notices
Lecture 24Evergreening - Patent Life Extension Strategies
Lecture 25LOE Strategies for Innovator Brands with case study
Lecture 26Pay For Delay Strategy
Lecture 27REMS Strategic Planning 
Lecture 28Compulsory Licensing
Lecture 29Licensing & Technology Transfer
Lecture 30In-Licensing Vs. Outlicensing
Lecture 31Paediatric Exclusivity and Paediatric Study Plan Development
Lecture 32Drug Repurposing
Lecture 33Practical Queries on different USFDA application and Filing 
Section 4Good Manufacturing Practices
Lecture 34Introduction to Good Manufacturing Practices
Lecture 35G1 Lecture Premises & Plant Layout Designing
Lecture 36G2 Lecture Sanitation and Hygiene
Lecture 37G3 Lecture Equipment
Lecture 38G4 Lecture Production
Lecture 39G5 Lecture Documentation
Lecture 40G6 Lecture Quality Control
Lecture 41G7 Lecture Product Complaint
Lecture 42G8 Lecture Storage Module
Lecture 43ISO and ISO Audits