Courses

  Advanced Post Graduate Diploma in Pharmacovigilance/Drug Safety (Argus Safety), Clinical Research, Clinical Data Management (Oracle Clinical) & SAS Clinical (Base SAS and Advance SAS) with Live Projects
  Advanced Post Graduate Diploma in
Regulatory Affairs
 

Features

 Job Oriented Certified Training
  Live Project Experience Certification
 Placement Assistance
 Reco Letters for Abroad
  Resume Preparation Tips
  Practical Hands-on training on Databases
  Argus Safety & Oracle Clinical Databases
Bio Med Informatics

Our Candidates are
Employed with

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

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

Module 2: Regulations in United States of America

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

Module 3: Regulations in European Countries

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

Module 4: ICH and WHO

arrow Harmonisation and its need
arrow ICH and the steps involved in forming ICH
arrow Guidelines of ICH
arrow Bioequivalence and Bioavailability
arrow Interchangeability
arrow WHO and its importance
 

Module 5: Regulations in Other Countries and Dossiers

arrow Conventional dossiers
arrow DMF & CTD
arrow Differences in EU and US regulations
arrow Regulations in Canada and its filing process
arrow Regulations in Japan and its filing process
arrow Regulations in India and its filing process
arrow Regulations in South Africa and its filing process
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Our Students are Alumni of

Our Students are Alumni of

BioMed in Media

Bio Specturum

Magazine

We are glad to say that BioSpectrum Magazine highlighted the name of BioMed Informatics, for its predominant role in the emerging technologies of Pharmacovigilance and Clinical Data Management. Even Dr. Ashok IAS, Director of Biotechnology, Government of Andhra Pradesh, highlighted BioMed Informatics, in his interview with Pharmabiz Magazine in Mumbai. Excerpts enclosed herewith.

 
 
Pharmabiz.com

Magazine

AP state Biotech Policy to be redrafted to make it more industry friendly: Dr A Ashok Mumbai.The Government of Andhra Pradesh is committed to harness the benefits of biotechnology in order to make a positive contribution to the life of the common man.

 
Times of India
Eenadu
Sakshi
Prajashakthi
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