Graduate/Post Graduate who would like to develop career in pharmaceutical regulatory affairs must be familiar with all regulations and guidelines. Person must have a thorough understanding of the regulatory documents which has been drafted. Regulatory professionals are the primary communication link between the company and global regulatory agencies such as USFDA (United States Food and Drug Administration) and European Union of Drug Regulatory Affairs (EUDRA). The pharmaceutical, biotechnology and medical device research and development industries are among the most highly regulated industries globally. As pharmaceutical sector is growing rapidly, there is a need of regulatory affairs professionals to cater the current needs of industries for the global competition. Regulatory affairs professionals are the link between pharmaceutical industries and worldwide regulatory agencies. They are required to be well versed with the laws, regulations, guidelines and guidance of the regulatory agencies.
As the pharmaceutical industries throughout the world are moving ahead towards becoming more and more competitive, they are realizing that the real battle of survival lies in executing the work by understanding the guidelines related to various activities carried out to give an assurance that the process is under regulation. 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.
In pharmaceutical company, prime responsibilities of these personnel involves preparation and presentation of registration documents to regulatory agencies and carry out all following discussion to obtain and maintain marketing authorization (MA) for the products concerned. In addition, regulatory personnel also advise companies both strategically and technically at the highest level. They play significant role right from development of a product to manufacturing, marketing and post marketing. Their advice at all stages both in terms of legal and technical requirements help companies save a lot of time and money in developing the product and marketing the same.
In recent years, we have been frequently hearing about the Intellectual Property Rights or IPR, in short. The idea of ownership has given rise to the concept of property. Till recently, the term property was always thought of in relation to some tangible assets, whose ownership could be established easily. In the new age of knowledge based society, the idea of having ownership rights in the intellectual creations has acquired strength and urgency. With globalization, India also has had to gear up for a paradigm shift from knowledge sharing society to knowledge owning society.
All the areas of Intellectual Property Rights are dealt in different countries as per their national laws. However, with the world turning into a global village, the markets of countries are also opening up to the products and services created elsewhere in the world. This has brought in the need of some international efforts to streamline the Intellectual Property Rights issues worldwide. The World Intellectual Property Organization (WIPO) is an international organization which helps to administer the treaties facilitating multinational intellectual property rights protection.
The information provided in this course material should not be construed as legal advice or legal opinion on specific facts unless so stated. This is not intended as a definitive statement on the subject but as a tool, providing practical information for the student.
MD, MS, MBBS, BDS, BHMS, BAMS, BUMS, BPT, B.Pharma, Graduate/Post Graduate Degree in Life Sciences, Pharmacology, Pharmacy, Medical Laboratory, Nursing, Biochemistry, Microbiology, Biotechnology and all professionals working with Pharmaceutical companies, CROs and hospitals.
Certificate would be awarded upon successful completion of the program. Program is certified & Accredited by the Pharmaceutical Society of India.
Duration: 6 Months
Fee: Fee Payable by Cash, Cheque / Bank draft in the name of ‘Fee can also be deposited in company bank account.
This course has especially been designed for the students who would like to develop their career in the field of regulatory, Upon completion of the program students would understand the concept of Regulatory Affairs in the field of pharmaceuticals, clinical research, patents & Pharmacovigilance; how the product is marketed in other countries, what are the legal requirements of regulatory bodies, procedure for the submission of documents etc. After completion of the program, students would become reasonably well versed in regulations governing pharmaceutical and clinical research domain.