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Pharma Chem Congress 2019

Journal of Pharmaceutical Chemistry & Chemical Science | Volume 3

June 12-13, 2019 | Bangkok, Thailand

OF EXCELLENCE

IN INTERNATIONAL

MEETINGS

YEARS

PHARMACEUTICAL

CHEMISTRY AND DRUG DISCOVERY

International Conference on

REGULATORY APPROVAL OF NEW DRUG DELIVERY SYSTEMS: BRIDGING THE GAPS

Ripal Gharia

Cliantha Research Ltd., India

ringing a new drug through discovery, clinical testing, development and regulatory approval is currently

estimated to take a decade and cost well over $120 million. Scientists are working on different aspects to

reduce this cost. New Drug Delivery System (NDDS) refers to the formulations, systems and technologies for

transporting a pharmaceutical compound in the body as it is needed to safely achieve its desired therapeutic

effects. NDDS technologies usually combine already approved drugs with different delivery system for either

same or different indication and/or route of administration. Regulatory approval process requires less preclin-

ical and clinical studies compared to NCE, but more than generics. NDDS can pose challenges regarding their

classification for authorization by regulatory agencies, particularly with respect to nanomedicine and nano-

technology. There are currently no specific requirements from the regulatory agencies (FDA and EMA) for the

preclinical and clinical testing of nanoparticle based drug delivery systems and only reflection papers providing

guidelines on the pharmaceutical development of a specific type of nanoparticle based drug delivery systems

have been published and to date the evaluation process follows a similar path as for small-molecule drugs. The

development of a new drug starts with preclinical testing followed by the submission of an Investigational New

Drug (IND) application in order to initiate the clinical trials. Intended therapeutic benefits needs to be taken

into account for designing preclinical and clinical studies. Application of quality by design concepts early in the

development will help the developer to build quality in and will ultimately improve clinical translation.

Ripal Gharia, J Pharm Chem Chem Sci 2019, Volume 3

Ripal Gharia currently working as Assistant General Manager at Cliantha Research Ltd., she has about 12+ years of working ex-

perience in clinical research. She is working as safety expert, medical monitor and medical writer mainly in therapeutic areas of

oncology, cardiology, dermatology, ophthalmology, urology, pain medicine, obstetrics and gynecology and respiratory for various

regulatory submissions such as FDA, EMA and DCGI. She was also conducted training programs for project teams located in India

and USA. She has a close rapport with KOLs and subject experts in various therapeutic areas. She is a part of more than 70+ studies

in different phases of drug development. She is interested in the areas of medical and regulatory affairs, pharmacovigilance, NDDS,

medical devices and vaccines.

BIOGRAPHY