Regulatory Affairs and IPR

The ethics involved within pharmaceutical sales is built from the organizational ethics, which is a matter of system compliance, accountability and culture Organizational ethics are used when developing the marketing and sales strategy to both the public and the healthcare profession of the strategy. A pharmaceutical Ethics and sales representative is the key part within the sales of all drugs. They are responsible to ensure the healthcare profession is informed of the benefits of the drug along with the safety and the side effects to assist a healthcare profession as the correct information and choices to prescribe medication to the patients. The term used is ethical promotion, which can be described as communication of ethical values to promote their product to the physician. 

Regulatory Affairs Department is the backbone of Pharmaceutical Industry. It is the revenue generator for pharmaceutical Industry. The Regulatory Affairs department is an important part of the pharmaceutical companies. More than 15 years span is required to develop and launch a new pharmaceutical product in the market. The Regulatory Affairs Agencies explains expenditure spent on each drug annually is $850 million in US. The Indian Pharmaceutical industry is one of the fastest growing industries in India, with a compounded annual growth rate (CAGR) of over 13 % in last 5 years and it is expected to grow at a higher rate in coming 10 years India spends around $300 million, united kingdom $700 , Brazil $200 million , France $550, Italy $400 As per cabinet decision in June 2010 in Japan amended a new policy i.e., Health power strategy through “Life Innovation” and expenditure spent on each drug was $450 million

It means the legal rights which result from intellectual activity in the industrial, scientific, literary and artistic fields.  Countries have laws to protect intellectual property for two main reasons: One is to give statutory expression to the moral and economic rights of creators in their creations and the rights of the public in access to those creations.  The second is to promote, as a deliberate act of Government policy, creativity and the dissemination and application of its results and to encourage fair trading which would contribute to economic and social development.  Intellectual property is a name that describes a class of several different legal regimes that generally concerns creations of the human mind. Copyright is but one of the legal regimes that fall under the umbrella of intellectual property.

  • Patents and disputes case studies
  • Identification techniques adulterated and misbranded drugs
  • FDCA (Federal Food, Drug, and Cosmetic Act )
  • Exemption in prescription and OTC drugs
  • Experimental animal ethics
  • Environmental health hazards
  • Developments in global intellectual property
  • Lifecycle management of drug products

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