biomedlifesciences.com BioMed Informatics Hyderabad : Regulatory Affairs Training

Company Name : BioMed Informatics (biomedlifesciences.com)
Location : Hyderabad
Training Offered : Advanced Post Graduate Diploma in Regulatory Affairs

http://www.biomedlifesciences.com/Projects-BioMedInformatics-Clinical-Research.html
http://www.biomedlifesciences.com/advanced-post-graduate-diploma-in-regulatory-affairs.htm

Advanced Post Graduate Diploma in Regulatory Affairs
Regulatory Affairs professionals are the link between pharmaceutical industries and worldwide regulatory agencies. Pharmaceutical industry, being one of the highly regulated industries, is in immense need of people than ever before who are capable of handling issues related to regulatory affairs in a comprehensive manner.

Regulatory affairs professionals play an essential role in ensuring all pharmaceutical products comply with regulations governing the industry.

Regulatory professionals are employed in industry and are involved with a wide range of products including pharmaceuticals, medical devices, in vitro diagnostics, biotechnology, nutritional products, cosmetics and veterinary products.

As regulatory processes increase in complexity and scope, and globalization occurs within the field, there will be continuing industry demand for people with a strong foundation in regulatory affairs. The Regulatory Affairs program provides professionals with the specialized knowledge required to help biotechnology, medical device, pharmaceutical and food companies manage regulatory processes.

The course would facilitate the participants with the understanding of the areas of regulatory affairs and quality operations to give students a thorough and up-to-date knowledge of federal laws and regulations as they apply to all stages of the development and commercialisation of pharmaceutical, biopharmaceutical and medical device products. At the end of program participants will be provided suitable placement assistance.

Course Curriculum
Module 1 : Introduction to the Regulatory Affairs
** Introduction and general overview of pharmaceutical industry
** Functions and types of dosage forms
** Definitions and various departments in the industry
** Regulatory Affairs as a profession and its importance
** Code of ethics of Regulatory Affairs professional
** Functions of Regulatory Affairs professional
** Importance of QA and its link with Regulatory Affairs
** Origin of drug development process and filings
** Innovation, creativity and its role in drug development and filings
** Importance of regulatory audits
** Overview of regulations worldwide and their origin (US, EU, Japan, Australia, Canada, UK, India)

Module 2 : Regulations in United States of America
** Origin of USFDA
** Food, Drug and Cosmetic Act (FDA)
** Code of Federal Regulations (CFR)
** Branches in USFDA and the function of each one of them, CDER, CBER, CDRH, CFSAN, CVM, ORA
** Procedure for marketing a drug in US
** Types of drug applications in US (ANDA, NDA, sNDA, 505(b)(2), BLA.etc)
** Detailed study about each of the drug applications
** Special emphasis on generic drug development and application procedure (ANDA)
** Sample flow chart on the development of a oral dosage form

Module 3 : Regulations in European Countries
** EU Commission
** European Medicines Agency (EMEA) including CHMP and CVMP
** National authorities of other EU countries
** Mutual recognition procedure
** Abridged application process
** Centralized procedure
** Decentralized procedure
** Orphan drug applications
** Guidelines and Eudralex
** EGA
** Biological similar

Module 4 : Regulations in Other Countries and Dossiers
** Conventional dossiers
** DMF & CTD
** Differences in EU and US regulations
** Regulations in Canada and its filing process
** Regulations in Japan and its filing process

Module 5 : ICH and WHO
** Harmonisation and its need
** ICH and the steps involved in forming ICH
** Guidelines of ICH
** Stability
** Dissolution
** Impurities
** Bioequivalence and Bioavailability
** Interchangeability
** WHO and its importance

Features :
Job Oriented Certified Training
Live Project Experience Certification
Placement Assistance
Reco Letters for Abroad
Resume Preparation Tips

Contact us :
BioMed Informatics
Medwin Hospitals
B Block, First Floor,
Nampally, Hyderabad- 500 001, India.