Saturday, 6 July 2024
Tuesday, 1 February 2022
Gigantic Influences of Medical Affairs in Healthcare Industry
Medical Affairs are departments within pharmaceutical and medical device companies responsible for communicating accurate information to healthcare providers. Medical Affairs acts as a bridge between the industry and the broader community of healthcare providers. This department is responsible for managing external relationships with major thought leaders in the scientific community across a wide range of therapeutic fields, as well as patient groups, authorities, and other stakeholders.
Medical Affairs in Healthcare Industry
WorkSure® Medical Affair services include medico-marketing and business development, medical communication, medical education and training, clinical research and regulatory activities, as well as KOL management and interfacing responsibilities. WorkSure® Medical Affairs service provides a comprehensive solution for pharmaceutical and healthcare organizations that deal with customers, patients, regulatory authorities, and doctors. With years of experience in therapeutic-based practices, our experienced team is well suited to assist our global clients with day-to-day challenges in the pharmaceutical industry. WorkSure® strives to meet the needs of its clients and provide complete product support.
Read more at https://lnkd.in/gyM55BqA
#medicomarketing #medicalaffaris #kolmanagement #medicaleducation #medicalcommunications
Friday, 31 December 2021
Happy New Year 2022
WorkSure wishes everyone Happy New Year 2022
#contractresearchoganization #clinicaldatamanagement
Saturday, 14 November 2015
Pharmacoeconomics: quantify the value of pharmacotherapy through balancing costs and outcomes
Monday, 5 October 2015
Excellence in regulatory documentation rendered by medical writer
Industries are helping medical research and communication activities
Newer treatments and bettering healthcare services are increasing life expectancy with improved quality of life. Various pharmaceutical, biotech industries and medical service KPOs are stepping forward to facilitate delivery of evidence based health care to the patients. WorkSure™, a growing name in healthcare KPO, has taken FMRC (Facilitated Medical Research Communication) initiative to help bridge the gap and increase India's share in biomedical research. This unique program is specially designed for assisting the Healthcare Fraternity to promote medical research at the level of hospitals, clinics as well as individual physician. WorkSure™ also promotes public private partnership in medical research and drug development.
Monday, 28 September 2015
Regulatory Medical writers A Document Focused Scientific experts
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| WorkSure |
Medical writer plays an important role in providing information to the targeted
audience. Regulatory medical writing
involves regulatory documents that are required before the approval of drug.
All new drug or chemical entity undergoes many level of test for its purity,
safety and efficacy. These include clinical study protocol, clinical study
report, patient consent form, summary document (common technical document). It is an internationally agreed format for the preparation of
applications regarding new drugs. It was developed by EMA, Europe (European
medical agency), FDA (Food and Drug Administration), MHLW, Japan (Ministry of
Health and Labour Welfare). The CTD is maintained by ICH (International
Conference of Harmonisation). The regulatory documents required are INDA
(Investigational New Drug Application), NDA (New Drug Application), and ANDA
(Abbreviated New Drug Application. The
regulatory writer prepares the document to be reviewed by FDA and for further
proceeding with the clinical trials. The strength of medical writer depends on its experience and
ability to understand well the regulation requirement by the corresponding
agengies. Other regulatory documents like Product
Monograph, Full Prescribing Information, Patient Information Leaflet, Summaries
of Product Characteristics (SPCs), Risk Evaluation and Mitigation Strategies
(REMS) etc. for both drugs and devices also be a part of regulatory document. The drug safety, quality, strength and purity
is assured by NDA to permit FDA for final submission.
The regulatory medical writer is an expert and
more specific than any other writer as they have to deals with the regulations
in ICH which involves application submission, withdrawal and termination of
particular drug. The regulatory medical writing team also involved in preparing
dossier, protocols for all clinical trial phases and application for INA, NDA,
CTA. As the detailed study of the drug
is to be compiled and documented, the writer must know about the statistical
analytical processes (SAP). They must be having good knowledge about the new
regulations and amendments in ICH. In pharmaceutical organisation and clinical
research organisation, the writer must be active to submit the information to
the regulatory agency when needed. The medical writer has the primary
responsibility for documentation of the specific areas such as CMC (Chemistry
Manufacturing Control), clinical and non-clinical. After the protocol
development at the clinical sites, the regulatory medical writer review SAP,
followed by clinical study report. The writer has ability to complete and
concise CSR that shows the result of clinical trials. Finally the results of
each CSR are to be submitted to the regulatory authority. This procedure from
developing protocol to the submission of document is undertaken by regulatory
medical writer. The work of regulatory medical writer is wide-ranging. They
have to face many challenges in pharmaceutical and clinical research
organisation. As an individual they have to look into the protocol design in
order to produce proper data out of the clinical trials necessary for labelling
of product, support in data analysis, and summarises the complicated data.
Additionally, Regulatory medical writer is always anticipated in the query resolution
and for advancement to the sponsors.
We at WorkSureTM have a specialized
team of regulatory medical writer. We deal with all type of regulatory document
IND, NDA and CTD. We are also involved in generating protocols for all phases
of clinical trials. We have the capability to work for regulatory agencies of
various countries including USA, Canada, Europe, Japan, India etc.