Post-authorization stage of product cycle | Pepgra

-

What is Product cycle?

In pharmaceutical industry, product cycle consists of all processes from drug discovery to launch to access, which is closely monitored by regulatory bodies like European Medicines Agency (EMA) for European Union (EU) and Food and Drug Administration (FDA) for us (US).

Post-authorization stage of product cycle.

The various stages include: –
  1. Discovery and development.
  2. Preclinical research.
  3. Clinical research with 3 phases.
  4. Regulatory body review.
  5. Post-authorization / Post-market monitoring.

Stage of post-authorization:

Drug efficacy and safety is studied extensively during clinical trials; however, this is often still inadequate and a continued study on an equivalent is required from the users. this is often done by feedback on an equivalent from the top users within the market once the drug is introduced. This decides the lifetime of the drug within the pharmaceutical market.

United States-Food and Drug Administration (US-FDA):

The US-FDA gives detailed guidelines on the varied aspects of drug development process including post-market drug safety monitoring.

European Union:

European Medicines Agency (EMA) gives elaborate scientific and regulatory guidelines including pharmacovigilance to pharmaceutical companies for those products approved in Europe.

Current Trends in EU:

  • Limitation is that PAS covers only certain types of patient care and not the entire spectrum.

Additional guidelines for specialised areas:

  • For e.g. in case of orphan medicines that are drugs used in the treatment of rare conditions like inherited errors of metabolism, PASS is important and quick access to this information is important for effective treatment.

To Continue Reading : Post-authorization stage of product cycle


pharmacovigilanceLiterature Search Services

BiostatisticsConsulting services

Regulatory Affairs services

Pharmaceutical Consulting Companies

Regulatory Affairs Consultant 


      Comments

      Post a Comment

      Popular posts from this blog

      Difference between Clinical Research Organization and Contract Research Organization(CRO)?

      -
      Image
      1.  A  contract research organization (CRO) organization that offers clinical trial and all kind of research support services outsourced on a contract basis to the pharmaceutical, biotechnology, and medical device industries and also serve government institutions, foundations, and universities.  2.  While contract research organizations can span the whole pharma pipeline from drug discovery to clinical trials and beyond, a clinical research company mostly manages clinical trials. 3. A contract research organization (CRO) sometime known as clinical research organization is the company or organization that helps conduct research for a sponsor company. This research can be ranges from pre-clinical development of new products to post marketing research activities. 4. CROs Play a major Role in Drug Development   5. One of the important ICH GCP guideline is followed to conduct clinical studies 6. A clinical research company mostly manages clinical trials.   ...
      Read more

      TIPS FOR SCIENTIFIC MEDICAL WRITING

      -
      Image
      Scientific medical writing involves writing detailed information about the essential medical sciences, drugs and latest technological innovation within the field of drugs for a variety of audiences including medical specialists and health care professionals. This scientific information is written for publication within the medical journals, medical news, and regulatory documents. MEDDEV (2.7/1) guidelines for CER documentation describe the various stages of planning, assessment, and evaluation of clinical data about medical a device to validate the clinical safety and functional performance of the concerned medical device. Some of the important procedures and documents involved in the CER development process include • Standard operating procedures for carrying out Clinical Evaluation • Quality System related procedures and protocols • Outlines for Clinical Evaluation Plan (CEP) and Clinical Evaluation Report. • Pre-market and post-post market CER • Clinic...
      Read more

      Difference Between Scientific Writing and Medical Writing | Pepgra.com

      -
      Image
      Scientific writing skills involve conveying the necessary information about a technology in various fields of life sciences such as, biotechnology, medicine, and engineering for publication or to explore new ideas to educationalists, scholars, and other professionals. It conveys information on novel innovations and theories which is essential for publishing and marketing academic journals and so on.The purpose of scientific writing companies   is to provide the useful information on a paper to grab the attention of readers and to make them understand the content.  In any situation if the document fails to convey the appropriate information, the reader may not understand the concept which might lead to lose their interest to read (Cristian A. Linte, 2014) . However, every one cannot be a good scientific writer, often it is difficult to put the innovative ideas on paper to document and bring it to the reader.  The poor writing will erode reader’s co...
      Read more