REGULATORY FRAMEWORK: VACCINE DEVELOPMENT IN US, INDIA AND EU


Regulatory Considerations for Gene Therapy Products in the US, EU, and Japan


Developers of gene therapy products (GTPs) must adhere to additional regulation beyond that of traditional small-molecule therapeutics, due to the unique mechanism-of-action of GTPs and the subsequent novel risks arisen. We have provided herein a summary of the regulatory structure under which GTPs fall in the United States, the European Union, and Japan, and a comprehensive overview of the reg...

analysis of legal framework of self-regulatory organizations in iran’ capital market with comparative study in the us legal system

in this paper, it’s been tried to examine the legalframework of self-regulatory organizations in iran and the us’scapital markets and to clarify this matter in iran and the us (as theinnovator of self-regulation method in some way for setting rules andregulations), with emphasis on laws and practices. to achieve thispurpose, we analyzed this matter from the most important angles;therefore, in t...

Gamete and Embryo Donation and Surrogacy in Australia: The Social Context and Regulatory Framework

Comparing the Active Centers in the Area of Ethics in Science and Technology in the US, UK, China and India

Background: Nowadays, life increasingly relies on inclusive scientific and technological infrastructures. Today, the use of technology has been manifested in all aspects of people's lives, so that decision-making processes in all aspects are based on the indicators of science and technology. Science has even come up with issues such as ethics and tradition, so traditional issues of ethics in th...

Vaccine Policy in India

0387 Vaccines are important preventive medicines for primary health care, and are a critical component of a nation’s health security. Although international agencies such as the World Health Organization (WHO) and the United Nations Children’s Fund (UNICEF) promote global immunisation drives and policies, the success of an immunisation programme in any country depends more upon local realities ...