The Placement Cell and Department of Pharmaceutical Regulatory Affairs, NGSMIPS along with GlaxoSmithKline, jointly organized the “GSK-Nitte University Guest Lecture Session 2024” on 21st November 2024 in online mode.
Mr. Vivek Pai K, Placement Officer, NGSMIPS formally welcomed the resource persons from GSK; Ms. Sharmila Shetty, Associate Director-Lead Project Emerald, Content Delivery, Global Regulatory Centre (India), GSK briefed about the guest lecture topics and the speakers.
Dr. R Narayana Charyulu, Principal, NGSMIPS greeted the participants and urged the students to utilize the program to its fullest.
Session 1: Fundamentals of Regulatory Affairs & Introduction to Quality Standards for Regulatory Compliance
Dhruvi Shah's presentation offered an in-depth look at Regulatory Affairs (RA) in India, emphasizing its role in drug development, approval, and market access while adhering to Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) standards. She outlined the Indian regulatory framework, highlighting the roles of CDSCO & DCGI, and underscored the importance of adapting to the evolving RA landscape through continuous learning.
Session 2: Overview - Regulatory Publishing
Chetna Thakur's presentation highlighted the vital role of regulatory publishing in the pharmaceutical industry, stressing adherence to standards like eCTD, data management, and format consistency. She emphasized cross-functional collaboration, the use of digital tools to streamline processes, and the need for continuous innovation to adapt to a dynamic regulatory landscape.
Session 3: Marketing Authorization Procedures in the USA & EU
Siddhartha T provided an overview of drug approval pathways in the US and EU. He explained the distinctions between NDA 505(b)(1) for novel drugs, 505(b)(2) for drugs using existing data, and ANDA 505(j) for generics in the US, highlighting differences in clinical trial needs. For the EU, he discussed the centralized approval process via EMA for multi-country market access. He also emphasized the role of digital tools and regulatory harmonization in streamlining approvals in both regions.
Session 4: Regulatory Information & Management
Srikanth V's presentation highlighted the importance of effective regulatory information management for compliance and speeding up drug development. He emphasized accurate, up-to-date data throughout a product's lifecycle, the use of digital tools for submissions and communication, and robust systems to manage large regulatory data volumes and ensure global compliance.
Session 5: Drug Labeling Overview
Kalp Jamalta's Drug Labeling Review session highlighted the importance of accurate labeling for product safety and compliance. It covered EU-specific requirements and provided an overview of global labeling regulations, offering key insights for industry professionals.
Session 6: Data Integrity Issues in the Pharmaceutical Industry with Case Studies (MSR Team)
Sai Sravani's session on data integrity emphasized the importance of ALCOA+ principles for ensuring accurate and reliable data. Through real-world scenarios and interactive Q&A, she provided valuable insights into maintaining robust data standards for regulatory and operational excellence.
Session 7: Changing Regulatory Guidelines & Intelligence Database Environment - Current Updates
Ramarao K and Pooja Warange's sessions explored the evolving regulatory landscape, emphasizing data integrity, PDCA cycle compliance, and regulatory intelligence. They detailed global drug regulatory authorities, ICH activities, and practical applications of regulatory intelligence, offering valuable insights for managing complex regulations effectively.
Session 8: Clinical Trial Application
Neel Patel's presentation highlighted key aspects of clinical trial applications (CTAs), emphasizing regulatory compliance, ethical principles, and robust data management. Covering the trial lifecycle from preclinical studies to post-marketing, he stressed diverse patient representation and the influence of international regulators. He also discussed risk management, digital tools, and adaptive trial designs, offering insights into the future of drug development.
Mr. Vivek Pai K, Placement Officer summarized the sessions and Dr. R Narayana Charyulu, Principal, NGSMIPS concluded the session with a thank-you note.
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