Regulatory Affairs associate

Online Training-Advanced Post Graduate Diploma in

Regulatory Affairs

BioMed Informatics Medwin Hospitals

(Established in the year of 2000)

1. Before joining in BioMed Informatics Medwin Hospitals, You are welcome to check the appointment letters of our previous students issued by MNCs like Novartis, Quintiles, Accenture, Cognizant, TCS, Parexel International (India) Pvt Ltd, MakroCare, Synowledge and so on.
2. We never make any phone calls to insist the candidates to join here by making empty promises.

Online Training Features:

• Web based classroom
• One faculty/student
• Placement support
• Regular/Fast track/Weekend batches
• Flexible timings
• Material will be provided 
• Training Mode: Skype/Teamviewer

BioMed Informatics Medwin Hospitals is a leading Clinical Research Organization offering trainings since the year of 2000 that are helpful for Pharmacy/Life Sciences students to enter into IT Companies and Pharma, Biotech, CRO industries.

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, Cognizant, TCS, Parexel International (India) Pvt Ltd, MakroCare, Synowledge, 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…

Certification
Certificate will be provided for this course on successful completion of Assignments & Projects. Certificate would be awarded at the end of the program by BioMed Informatics

Medwin Hospitals.

Interested candidates are kindly requested to fill Enquiry Form in the website www.biomedlifesciences.com for further information.

Contact:

G.V.L.P.Subba Rao                        

Mobile: 9989684450

BioMed Informatics (Established in the year of 2000)

Medwin Hospitals B Block First Floor,

Nampally, Hyderabad – 500 001

Phone: 040 – 40209750

Website: 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: ICH and WHO

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

Module 5: 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
• Regulations in India and its filing process
• Regulations in South Africa and its filing process

-----------------------------------------------------------------------------------------------------------------

BioMed Informatics, Medwin Hospitals (Established in the year of 2000) www.biomedlifesciences.com offers the following courses

• Class Room Training - Advanced PG Diploma in Pharmacovigilance/Drug Safety in Oracle Argus Safety Database with Practical Hands on Training - Project Experience Certification & Placement Assistance

• Online Training – Pharmacovigilance/Drug Safety in Oracle Argus Safety Database with Practical Hands on Training with Project

• Online Training-Pharmacovigilance Drug Safety Physician/Medical Reviewer

• Online Training-Argus Safety Configuration

• Online Training - Clinical Data Coordinator/Clinical Data Management in Oracle Clinical OC/RDC with Practical Hands on Training with Project

• Online Training-SAS Clinical (Base SAS, Advance SAS and Biostatistics) with Project

• Online Training- Clinical Data Analyst with Project

• Online Training-Advanced Post Graduate Diploma in Regulatory Affairs

• Online Training- SAS CDISC SDTM, ADaM, TLF/TL