Pharmaceutical Regulatory Affairs plays a pivotal role in ensuring the safety, efficacy, and quality of pharmaceutical products, acting as the liaison between pharmaceutical companies and regulatory authorities. This dynamic field navigates the complex landscape of regulations and guidelines, shaping the development, manufacturing, and marketing of drugs.
Professionals in Regulatory Affairs are responsible for interpreting and implementing regulatory requirements to ensure compliance throughout the drug development lifecycle. They work closely with cross-functional teams to strategize and execute regulatory submissions, seeking approvals from health authorities such as the FDA, EMA, and other regulatory bodies worldwide.
The regulatory landscape is ever-evolving, and Regulatory Affairs professionals stay abreast of changes, guiding companies through the intricacies of new guidelines and ensuring adherence to established standards. They contribute to the successful launch and post-marketing surveillance of pharmaceutical products, addressing challenges related to labeling, safety reporting, and product recalls.
Pharmaceutical Regulatory Affairs professionals also play a crucial role in fostering international harmonization, facilitating global drug development and access. Their expertise is instrumental in navigating the complex web of regulations, ultimately contributing to the availability of safe and effective medicines for patients worldwide.
Title : The impact of metal-decorated polymeric nanodots on proton relaxivity
Paulo Cesar De Morais, Catholic University of Brasilia, Brazil
Title : Hepatotoxic botanicals-shadows of pearls
Consolato M Sergi, Universities of Alberta and Ottawa, Canada
Title : Exploring classical ayurvedic drugs in hypertension
Prashant Bhokardankar, Datta Meghe Ayurved College, India
Title : Principles and standards for managing healthcare transformation towards personalized, preventive, predictive, participative precision medicine ecosystems
Bernd Blobel, University of Regensburg, Germany
Title : Personalized and Precision Medicine (PPM) as a unique healthcare model based on design-inspired biotech- & biopharma-driven applications to secure the human healthcare and biosafety
Sergey Suchkov, N.D. Zelinskii Institute for Organic Chemistry of the Russian Academy of Sciences & InMedStar, Russian Federation
Title : A unique role and and impact of catalytic antibodies (abzymes) in clinical practice: A novel strategy for predicting and preventing relapse in chronic autoimmune conditions
Sergey Suchkov, N.D. Zelinskii Institute for Organic Chemistry of the Russian Academy of Sciences & InMedStar, Russian Federation
Title : The promise of nanotechnology in personalized & precision medicine: Drug discovery & development being partnered with nanotechnologies via the revolution at the nanoscale
Sergey Suchkov, N.D. Zelinskii Institute for Organic Chemistry of the Russian Academy of Sciences & InMedStar, Russian Federation
Title : The promising future of the unique translational tool to manage beta-cell population renewal and regeneration to secure the post-diabetic period
Sergey Suchkov, N.D. Zelinskii Institute for Organic Chemistry of the Russian Academy of Sciences & InMedStar, Russian Federation
Title : Easily injectable, organic solvent free self assembled hydrogel platform for endoscope mediated gastrointestinal polypectomy
Hitasha Vithalani , IIT Gandhinagar, India