www.biomedlifesciences.com BioMed Informatics Hyderabad : Regulatory Affairs Training

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Company Name : BioMed Informatics
Location : Hyderabad
Training Offered : Advanced Post Graduate Diploma in Regulatory Affairs

http://www.biomedlifesciences.com/Pr...-Research.html
http://www.biomedlifesciences.com/ad...ry-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.

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BioMed Informatics Medwin Hospitals (Member of BCIL-DBT) is a leading Clinical Research organization offering full range of Clinical Research, Clinical Data Management, Oracle Clinical OC/RDC, Pharmacovigilance, Oracle Argus Safety & SAS Clinical training services to Healthcare Organizations globally since the year of 2000.

The classes will be conducted at BioMed Informatics Medwin Hospitals, Hyderabad.

Oracle Argus Safety is an advanced and comprehensive adverse events (AE) management system that helps life sciences companies enable regulatory compliance, drive product stewardship, and integrate safety and risk management into one comprehensive platform. Argus Safety is industry-proven and accepted, having been used for more than a decade at leading Pharmaceutical, Biotech, CRO, and IT Companies. Trainees get hands on practical training experience to create career paths.

The focus of the Pharmacovigilance training in Oracle Argus Safety mainly includes the following topics:

** Clinical Development process
** Different phases of Clinical Trials
** History and overview of Pharmacovigilance
** Introduction and responsibilities of USFDA, EMA and CDSCO
** Pharmacovigilance in India
** Adverse Events and its types
** Drug Safety in clinical trials and post marketed drugs
** Different sources of Adverse Events reporting
** Different types of AE Reporting Forms
** Expedited reporting and its timelines
** Different departments working on Pharmacovigilance
** Roles and responsibilities of case receipt unit
** Roles and responsibilities of Triage unit
** Four factors for the reportable case
** Seriousness criteria of adverse event
** Expectedness or Listedness of adverse event
** Causality assessment of the adverse event
** Importance and procedure of duplicate check
** Data Entry
** Case booking or initiation
** Case processing
** MedDRA and WHODD coding
** SAE narrative writing
** Case quality check, Medical review and its submission
** PSUR and its submission timelines

Mode of Training: Instructor Led Class room/Online Training

Online Training Features:
** Web based classroom
** One faculty/student
** Placement support
** Regular/Fast track/Weekend batches
** Flexible timings
** Training Mode: Skype/Teamviewer

Our candidates employed in Novartis, Quintiles, Parexel International (India) Pvt Ltd, MakroCare, 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 the enquiry form in the website www.biomedlifesciences.com for further information.

Please note that we also provide separate hostel facility assistance for ladies as well as gents.

Contact:
G.V.L.P. Subba Rao
BioMed Informatics
Medwin Hospitals B Block First Floor,
Nampally, Hyderabad-500 001, India
Website: www.biomedlifesciences.com