Advanced PG Diploma in Regulatory Affairs
BioMed Informatics Medwin Hospitals
BioMed Informatics Medwin Hospitals
Features:
• Certificate will be provided after successful completion of the course
• Job experience certificate will be provided till you are getting placement, because of availability of data with us from time to time
• Job experience certificate will be provided till you are going to abroad
• This is the only place in India where you can get job experience certificate because of availability of data. This job experience certificate will be very much useful in shortlisting process by companies
• Relieving certificate will be provided after getting the job
• Resume preparation tips / Interview guidance
• Printed material will be provided
Medwin Hospitals, a Multi Speciality Hospital with excellence in modern health care ventures BioMed Informatics (Member of BCIL-DBT) in the field of Clinical Research & Regulatory Affairs by keeping in view of the tremendous applications in improving the quality of the health care.
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.
Our candidates employed in Novartis, Quintiles, Parexel International (India) Pvt Ltd, Global Hospitals, Apollo Hospitals, NIMS, Glenmark Pharmaceuticals Ltd, Jubilant, Reliance Life Sciences, Shantha Biotechnics Ltd, Mahindra Satyam, SMO Clinical Research (I) Pvt Ltd, Pioneer Corporate Services Inc-USA, ICMR, AstraZeneca-UK, Texas Woman’s University-USA and many more…
Interested candidates are kindly requested to fill the enquiry form in the website http://www.biomedlifesciences.com for further information.
Please note that we also provide separate hostel facility assistance for ladies as well as gents.
Thanking you,
G.V.L.P. Subba Rao
BioMed Informatics
Medwin Hospitals B Block First Floor,
Nampally, Hyderabad-500 001, India
Phone: 040 - 40209750
Website: http://www.biomedlifesciences.com
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