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Online Training - Medical Writing / Scientific Writing with Experience Certification & Placement Assistance, Medical Writing / Scientific Writing certificate course in Hyderabad, India consists of online Medical Writing training / online Scientific Writing 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. Medical Writing online Training / Scientific Writing online Training also offered in Hyderabad, Chennai, Bangalore, Mumbai, Pune, Delhi, Kolkata. BioMed Informatics Medwin Hospitals Online Training complimented as the best Medical Writing Training in Hyderabad, best Medical Writing Training in Chennai, best Medical Writing Training in Bangalore, best Medical Writing Training in Mumbai, best Medical Writing Training in Pune, best Medical Writing Training in Delhi, best Medical Writing Training in Kolkata, best Medical Writing Training in India. Medical Writing / Scientific Writing online training institute features include Interactive one to one online live sessions, one faculty/student, Regular/Fast track/Weekend, Flexible timings, Online Training via Skype/TeamViewer with course material and resume preparation tips.

Online Training - Medical Writing / Scientific Writing with Experience Certification & Placement Assistance

BioMed Informatics Medwin Hospitals, Hyderabad, India is a leading Clinical Research Organization offering best Medical Writing Training in Hyderabad since the year of 2000. Online Medical Writing Training in Hyderabad, India includes best Medical Writing Training online Institute that imparts knowledge about Clinical Trial Documents. Medical writing certificate course is valuable for professionals to scale up their career. BioMed Informatics Medwin Hospitals Online Training complimented as the best Medical Writing Training in USA, best Medical Writing Training in UK, best Medical Writing Training in Australia, best Medical Writing Training in Germany, best Medical Writing Training in Sweden, best Medical Writing Training in Netherlands, best Medical Writing Training in Singapore, best Medical Writing Training in Europe, best Medical Writing Training in Canada. Training in Online Medical Writing is very much helpful for the professionals planning to switch over their jobs or even for fresh jobs too. With the rising innovations and the rapid growth in healthcare sector, the demand for medical documents especially pertaining to clinical research has been increased. Medical Writing, as a profession is therefore, constantly growing and is now in the spotlight in pharmaceutical industry & IT industry. Overall, medical writing is one of the most promising careers nowadays, owing to the growth opportunities. Rapid growth in the Medical Writing / Scientific Writing business has translated into a huge demand in the number of Medical Writers. Life Sciences, Pharmaceutical Sciences and Medical Graduates, Post Graduates and PhDs have started moving into Medical Writing / Scientific Writing sector. Professional are seeking Medical writing as the preferred choice for their careers across the Globe like India, USA, UK, Australia, Germany, Sweden, Netherlands, Singapore, Europe and Canada.

Medical Writing Training

Medical Writing Training equips you the knowledge related to Safety Writer Jobs, Clinical Medical Writer Jobs, Medical Affairs Writer Jobs, Medical Regulatory Writer Jobs, Scientific Writer Jobs in addition to Medical Writer Jobs.

Medical Writing Training / Safety Writing Training in Clinical Research focuses on the documents that need to be submitted to the regulatory authorities at various stages of a clinical trial. Medical Writing is required through the entire life cycle of a drug - starting at the preclinical development stage and going right through to continued monitoring of drugs once they hit the market. The process for new drug approvals relies heavily on the quality of documentation submitted to the regulatory authorities, and a high standard of medical writing plays a vital role in ensuring a positive outcome.

Are you looking for an opportunity to support a business creating life-saving treatments? If you're looking to boost your career prospects in the pharmaceutical industry, medical writing training is a great string to add to your bow. Whether you want to move into clinical research or enhance your profile in your existing company, Medical Writing training is crucial. Compliance to European and American Medical Writing regulations is important as enormous opportunities available in United States of America, United Kingdom and other European Countries.

Brexit and implementation of the new regulatory base of Medical Writing in the UK as well as in the Eurasian Economic Union (EAEU) countries, have transformed Medical Writing to a key element brought to the attention of all pharmaceutical industry players. For years, a globally harmonized approach to Medical Writing has been discussed as a concept for integrated regulations. Considering the recent developments, we are Getting Closer Harmonized systems.

Medical Writing Training Online

Looking for professional medical writing training / safety writing training? If you hold an associate's degree or higher and want to advance your career in Medical Writing or want to increase your skillset with the Safety Writing, our Online Training - Medical Writing/Scientific Writing with Flexible Timings & Experience Certification with Placement Assistance is right for you to boost your career. Our Medical Writing training online / Safety Writing training online focuses on ICH-GCP/FDA (US)/EMEA (Europe, the Middle East and Africa)/Canada (Health Canada)/TGA (Australia)/MHRA (UK) guidelines. Unique program designed for professionals aspiring to make a career in Medical Writing / Safety Writing.

Online Training Features

  • Web based classroom
  • One faculty/student
  • Placement support
  • Regular/Fast track/Weekend individual slot
  • Flexible timings
  • Training Mode: Skype/Teamviewer

Certification

Course Certificate & Job Experience Certificate would be awarded at the end of the program.

Course Curriculum

  • Clinical Study Reports (CSRs)
  • Clinical Study Protocol
  • Clinical Protocol Amendments
  • Clinical Trial Reports
  • Patient Safety Narratives
  • Narratives for Adverse Drug Reactions & Adverse Events
  • Regulatory Documents
  • Quality Checks QC / Quality Review QR
  • US FDA Guidelines
  • EU & Other Foreign Regulations
  • Drug Development Process
  • Global Regulatory Submissions
  • New Drug Application (NDA)
  • IND Submissions
  • Abbreviated New Drug Application (ANDA)
  • Institutional Review Board (IRB)
  • Electronic Code of Federal Regulations (eCFR)
  • Independent Ethics Committee (IEC)
  • Investigator Brochures (IBs)
  • Informed Consent Forms (ICFs)
  • Data Collection Documents
  • Source Documents
  • Investigational Medicinal Product Dossier (IMPD)
  • Standard Operating Procedures (SOPs)
  • ICH/GCP Guidelines
  • Case Report Forms (CRFs)
  • eCRF
  • Regulatory Submission Documents
  • Aggregate Safety Reports
  • Periodic Safety Update Reports (PSURs)
  • Periodic Benefit Risk Evaluation Reports (PBRERs)
  • Periodic Adverse Drug Experience Reports (PADERs)
  • Development Safety Update Reports (DSURs)

You will be extensively involved in

  • Reviewing Clinical Study Reports (CSRs)
  • Clinical Trial Protocol Review
  • Reviewing Informed Consent Forms, Case Report Forms
  • Clinical Data Quality Check
  • Writing Patient Safety Narratives
  • Knowledge about Drug Development Process
  • Quality Review of Regulatory submission documents
  • Reviewing IB, SOPs
  • Knowledge about US FDA/EU/ICH-GCP Guidelines
  • Regulatory Submission Documents Review
  • Review of Aggregate Safety Reports : Periodic Safety Update Reports (PSURs), Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs)

Medical Writing Associations

  • American Medical Writers Association (AMWA)
  • European Medical Writers Association (EMWA)
  • Australasian Medical Writers Association (AMWA)
  • Indian Medical Writers Association (IMWA)
  • Chinese Medical Writers Community (CMWC)

Medical Writing Global Regulations

  • Australia - Therapeutic Goods Administration (TGA)
  • New Zealand - MEDSAFE
  • North America
  • Canada - Health Canada
  • USA - FDA: Food and Drug Administration
  • Central/South America
  • Argentina - ANMAT
  • Brazil - Agencia Nacional de Vigilancia Sanitaria (ANVISA)
  • Chile - Instituto de Salud Publico (ISP)
  • Columbia - Instituto Nacional de Vigilancia Medicamentos y Alimentos (INVIMA)
  • Costa Rica - Ministerio de Salud
  • Cuba - CECMED
  • Dominican Republic - Direccion General de Drogas y Farmacias
  • Jamaica - Ministry of Health
  • Mexico - Comision Federal para la Proteccion contra Riesgos Sanitarios (COFEPRIS)
  • Paraguay - Ministro de Salud Publica y Bienestar Social
  • Peru - Ministerio de Salud
  • Uruguay - Ministerio de Salud Publica
  • European Union - EMA: European Medicines Agency
  • Armenia - Scientific Centre of Drug and Medical Technology Expertise
  • Austria - Agency for Health and Food Safety (AGES)
  • Belgium - Federal Agency for Medicines and Health Products
  • Bulgaria - Bulgarian Drug Agency
  • Croatia - Agency for Medicinal Products and Medical Devices of Croatia
  • Cyprus - Ministry of Health
  • Czech Republic - State Institute for Drug Control
  • Denmark - Danish Medicines Agency
  • Estonia - State Agency of Medicines
  • Finland - Finish Medicines Agency
  • France - Agence Nationale de Securite du Medicament et des Produits de Sante
  • Germany - Federal Institute for Drugs and Medical Devices
  • Georgia - Regulation Agency for Medical and Pharmaceutical Activities
  • Greece - National Organisation for Medicines
  • Hungary - National Institute of Pharmacy
  • Iceland - Icelandic Medicines Agency
  • Ireland - Irish Medicines Board
  • Italy - National Institute of Health
  • Lithuania - State Medicines Control Agency
  • Luxembourg - Ministry of Health
  • Malta - Maltese Medicines Authority
  • Moldova - Medicines Agency
  • Netherlands - Medicines Evaluation Board
  • Norway - Norwegian Medicines Agency
  • Poland - The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
  • Portugal - National Authority of Medicines and Health Products
  • Romania - National Medicines Agency
  • Russia - Ministry of Health of the Russian Federation
  • Serbia - Medicines and Medical Devices Agency of Serbia
  • Slovakia - State Institute for Drug Control
  • Slovenia - Ministry of Health
  • Spain - Spanish Medicines Agency
  • Sweden - Medical Products Agency
  • Switzerland - Swiss Agency for Therapeutic Products
  • Ukraine - Ministry of Health
  • United Kingdom - Medicines and Healthcare Regulatory Agency (MHRA)
  • Bahrain - I-SEHA
  • Egypt - Ministry of Health
  • Iran - Ministry of Health
  • Israel - Ministry of Health
  • Jordan - Jordan Food and Drug Administration
  • Lebanon - Ministry of Public Health
  • Saudi Arabia - Saudi Food and Drug Authority
  • United Arab Emirates - Ministry of Health
  • Bangladesh - Directorate General of Drug Administration (DGDA)
  • Bhutan - Drug Regulatory Authority
  • China - CFDA/NMPA: State Food and Drug Administration
  • India - Central Drug Standards Control Organization (CDSCO)
  • Indonesia - POM (Pengawas Obat dan Makanan)
  • JAPAN - PMDA: Ministry of Health, Labour and Welfare
  • Korea (South) - Korean Food and Drug Administration (KFDA)
  • Laos - Food and Drug Department
  • Malaysia - Ministry of Health (MOH)
  • Nepal - Department of Drug Administration
  • Philippines - Department of Health (DOH)
  • Singapore - Health Sciences Authority (HSA)
  • Sri Lanka - Ministry of Health (MOH)
  • Taiwan (Republic of China) - Taiwan Food and Drug Administration (TFDA)
  • Thailand - Food and Drug Administration of Thailand
  • Vietnam - Drug Administration of Vietnam
  • Algeria - Ministry of Health and Population
  • Botswana - Ministry of Health (MOH)
  • Burkina Faso - Le Ministere de la Sante
  • Ghana - Food and Drugs Authority
  • Kenya - Pharmacy and Poisons Board
  • Morocco - Ministry of Health
  • Nigeria - National Agency for Food and Drug Administration and Control
  • Rwanda - Ministry of Health
  • Senegal - Ministere de la Sante et de l'Action Sociale
  • South Africa - Medicines Control Council (MCC)
  • Swaziland - Ministry of Health
  • Tanzania - Tanzania Food and Drug Authority (TFDA)
  • Uganda - National Drug Authority