Courses

  Online Webinar Training - Two days Training with Certificate in Pharmacovigilance with Argus Safety database
  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 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-Advanced Post Graduate Diploma in Regulatory Affairs
  Online Training- SAS CDISC SDTM, ADaM, TLF/TLGs
  Online Training - CTD/eCTD
Regulatory Affairs training certificate course provided by BioMed Informatics Medwin Hospitals Hyderabad, India consists of online Regulatory Affairs training for the students across the Globe to Countries like India, USA, UK, Australia, Germany, Sweden, Netherlands, Singapore, Europe and Canada over World Wide Web. Regulatory affairs online certificate training institute features include Interactive one to one online sessions, one faculty/student, Regular/Fast track/Weekend, Flexible timings, Training via Skype/TeamViewer with course material and resume preparation tips.
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Bio Med Informatics
 
Hands on Practical Training in Oracle Argus Safety Database (Pharmacovigilance) & Oracle Clinical OC/RDC (CDM).

Our Candidates are
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Online Training-Advanced Post Graduate Diploma Regulatory Affairs

Regulatory Affairs professionals are the link between pharmaceutical industries and worldwide regulatory agencies like USA, UK, Canada, European Union, India, Japan, Australia. 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 History, Development and scope of International and Indian Pharmaceutical Legislations
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: Regulatory Affairs – USA

arrow History of Drug regulation in US
arrow Organization and functions of FDA
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, INDA
arrow Investigational New Drug Application
arrow New Drug Application
arrow ANDA
 

Module 3: Regulatory Affairs - European Countries and Japan

arrow Regulatory Authorities in EU: Introduction and Organisation
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 Eudralex Guidelines
arrow EGA
arrow Biological similar
arrow Differences in EU and US regulations
arrow Overview of Japan Regulatory Agency
arrow Drug Approval Process in Japan
 

Module 4: Regulatory Affairs - Other Major Countries

arrow Regulation process in UK
arrow Drug Approval Process in India
arrow Regulatory Process in Australia
arrow Regulatory Process in Canada
arrow Regulations in South Africa
 

Module 5: ICH and WHO

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

Module 6: Dossiers

arrow Conventional dossiers
arrow DMF & CTD
arrow Intellectual Property Right Management
arrow Laws related to Drug Product design, Safety & Environment
 
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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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