About the Programme:
The course will give knowledge aboutIntellectual Property and Regulatory Affairs in Pharma industry.
Intellectual Property (IP) protection is crucial for the pharmaceutical industry, as it provides companies with the ability to recoup their research and development investments, and fosters innovation by incentivizing new discoveries.
Regulatory Affairs (RA) is a complex and constantly evolving field, and understanding and complying with regulatory requirements is essential for successfully developing and commercializing new drugs.
RA plays a critical role in ensuring the safety and efficacy of new drugs, which is essential for protecting public health and building trust in the pharmaceutical industry.
Collaboration between companies, research institutions, and regulatory authorities is crucial for the development and approval of new drugs, and for ensuring that they meet regulatory requirements.
Risk management is essential for identifying and mitigating potential risks associated with new drugs, and for communicating these risks to healthcare providers and patients.
The pharmaceutical industry operates in a global market, and navigating regulatory requirements in different countries and regions can be challenging. It is important to understand and comply with international regulations to ensure global access to new drugs.
Objectives of the program:
- Protecting the innovations and inventions that drive pharmaceutical research and development, including drugs, vaccines, and medical devices, through patents, trademarks, and copyrights.
- Providing a legal framework for licensing and transferring intellectual property between companies, research institutions, and investors.
- Establishing a competitive advantage for pharmaceutical companies by enabling them to differentiate their products from those of their competitors and secure market exclusivity.
- Encouraging investment in research and development by providing a mechanism for companies to recoup their investments and earn a return on their intellectual property.
Topics to be covered:
- Intellectual Property
- Regulatory Affairs
- Combination products
- Global regulatory affairs
- Biologics
- Risk management
Programme Committee:
Chief Patron
Chairman
Dr. P. Rajeshwar Reddy,
M.Sc, Ph.D.
Secretary and Correspondent
Patron
Dr. M. Chinna Eswaraiah,
M. Pharm, Ph.D.
Principal
Convener
Dr. S. Jaya,
M. Pharm, Ph.D.
Professor
Department of Pharmaceutics
Email ID: jayamay21@gmail.com
Contact number: 9908778846
Coordinator
Mrs. V. Hima Bindu
M. Pharm,
Assistant Professor,
Department of Pharmaceutics,
Email ID: bindu.palle1818@gmail.com
Contact number: 9110550530
Resource Person:
Ms. K. Kavitha,
M. Pharm,
Assistant Professor,
Department of Pharmacology,
Chalapathi Institute of Pharmaceutical Sciences, Guntur, Andhra Pradesh.
Email ID: kumpatikavitha77@gmail.com
Contact number: 7729939928
Address for Communication:
Mrs. V. Hima Bindu
M. Pharm,
Assistant Professor
Department of Pharmaceutics
Email ID: bindu.palle1818@gmail.com
Contact number: 9110550530
Last date to Registration: 30/09/2021
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