Course Objective – Pharmaceutical Regulatory Affairs courses are conceptualized with vision to create effective Regulatory Affairs Manager for Pharma Industry. This course gives practical knowledge of the functionalities of Regulatory Manager with practical exposure. This is ideally suits to those who wants Drug Regulatory Affairs Certification within a span of 1 month.
Career in Drug Regulatory Affairs
A career in Regulatory Affairs is both a challenging and highly rewarding career. It opens up lot of opportunities as it covers a variety of disciplines. Individuals who are directly involved in regulatory submission, compliance, clinical trials, quality assurance, drug safety, pharmacovigilance and others are considered regulatory professionals.
The Pharma industry is growing at a rapid pace and there is a rising concern over the safety and efficacy of pharmaceutical and medical device products. To maintain safety and efficacy in pharma & medical device products, regulatory agencies like US FDA,UK MHRA, EDQM, DCGI etc all over the world are imposing no of regulation. This has resulted in creation of distinct department with highly qualified professionals who will help companies meet these requirements with ease.
1. 6 different Printed Book / printable booklet provided to all course registrant
2. Access the e-lectures, case studies, self assessment modules and practical sessions through personalized webpage. Refer Learning Schedules by scrolling down the page.
3. Flexible online final examination (Computer Based Test by secure mode)
4. Access to real life case studies
The Internationally Accredited course – Accredited by International Association of Distance Learning (IADL), UK
Knowledge Process Enhancer is registered under Trademark Registry of India, under class 42.
Minimum qualification required is Graduation in any discipline or 2 years of work experience in pharmaceutical company.
View comparison of 1 Week / 1 month / 1 Year program.
|Study Module – [Downloadable E-book]||18 no.||You can download, save and print.|
|E-lectures||190 sessions||Each session of 1 hour – 5 hour duration|
|Handout of Electures||Yes||You can download and save.|
|GMP Audit Format||170 Pages exclusive audit format||Open file, you can modify and use for own purpose|
|Dossier Format||Sample dossier of 160 Pages open file will be provided.||You can download and use for own purpose.|
|Final Examination||Online, MCQ type|
|Course complete certificate||Yes||You can request only after 4 month of the completion of the course.|
|Course examination result and gradation certificate||Yes||Will be issued within 48 hours after completion of the final examination|
Course Content / Learning Schedules