somnath basu

CEO

Delhi, India37 yrs 10 mos experience

Most Likely To SwitchHighly Stable

Key Highlights

Over 6 years of expertise in drug regulation.
Key contributor to India's vaccine vigilance assessment.
Led development of significant drug regulatory frameworks.

Stackforce AI infers this person is a Healthcare Regulatory Expert with extensive experience in drug and vaccine regulation.

Contact

Skills

Core Skills

Drug RegulationQuality AssuranceAnalytical Techniques

Other Skills

Technical Dossier ReviewMarket AuthorizationPharmaceutical ProductsMedical DevicesBiological DrugsPharmacovigilanceRegulatory AssessmentCollaborationVaccine VigilanceRegulatory Framework DevelopmentPolicy MakingInstrumental AnalysisMicrobial Assay TechniquesDocumentationQuality Control

About

With basic education in CHEMISTRY (hons.) & BIOCHEMISTRY (Masters) including chapters on Molecular Biology, Microbiology & Genetics, and Ph.D. from Calcutta university , worked in CDL-Calcutta (a WHO collaborating center) and National Appellate lab for analysis of "Drugs", acquired >6-years skill in analytical techniques of HPLC / GC/ IR / Microbial Assay, Working in CDSCO as team leader of the Reviewer for Regulation of New drugs, recombinant drugs, Vaccine, Stem Cell therapeutics, Medical devices, In-vitro Diagnostics and worked as focal person in WHO-NRA assessment since 2007 onwards and strengthening of Indian Drug Regul. Authority. I participated and presented in number of National & International Seminars (US-FDA & WHO, PMDA-Japan). In this journey associated with various Deptt. of Min. of Health/ Min. of Revenue/ Min. of agriculture, QCI, BIS, NIB, IPC, PvPI, AEFI sectt. Immun. Divn. GoI, CDL(Kasauli), DBT, THSTI/ CDSA, Deptt. of Anim. Husb etc.

Experience

37 yrs 10 mos

Total Experience

14 yrs 11 mos

Average Tenure

31 yrs

Current Experience

Who workshop, training

2 roles

Trainee

Jan 2014 – Jan 2015 · 1 yr

Trainee

Jan 2008 – Jan 2015 · 7 yrs

National regulatory authority (nra) for "drugs"

Team Leader of reviewers of "drugs"

Apr 1995 – Present · 31 yrs · Greater Delhi Area

Working at India's National Regulatory Authority (NRA) for Pharmaceuticals, Cosmetics and Medical Devices since April, 1995 till date, as reviewer & assessor of Technical dossier for CMC, Pre-clinical (animal & lab.) & Human Clinical studies (incl. BA / BE / PK /PD studies), for Market Authorization (MA) of Pharma. Products, Medical devices and Biological Drugs i.e. r-DNA tech. based therapeutic proteins / monoclonal antibodies, Vaccines [Toxoids, Polysaccharide conjugate, killed / inactivated, whole virus / Split Virion based, Virus Like particle (VLP) and DNA / RNA based], Blood Products animal vaccines and Stem Cell Based Therapeutic products.
QA divisional activities in supervising capacity
Worked in close collaboration with WHO in regulation of Human Vaccine and participated in NRA assessment by international Team of experts endorsed by the WHO in 2007, 2009, 2012, 2017. instrumental role played by achieving Level-4 in NRA assessment for India in regard to Vaccine vigilance.
Participated in International Seminars (USA) organized by CDER & CBER on regulatory aspects of "Drugs" (chemical & biological origin).
Evaluated performance data (Specificity & Sensitivity) of IVD kits, contributed in AHWP, and National comm. for developing "Essential IVD List". Participated in framing of "New Drugs and Cosmetics Bill, 2015", Involved in National apex groups for review of GLP compliance of DBT, Modalities for Medical device standardization of QCI, BIS etc. AEFI Co-Ordinator for CDSCO
Worked in Hyd. and reviewed Inspection reports, import / export consignments since July,15. was in-charge pharma analysis at CDTL (hyderabad) lab. since Oct. 15 till date
preparing Guideline for IVDs mfgd. in India PBRER, PSUR data / reporting of Vaccines, Works related to WHO NRA Assessment. *participating in National AEFI committee. Instrumental in Med. Dev. Rule2017 w.e.f. jan 2018, developed guideline for Pharmacovigilance Inspection,

Drug RegulationTechnical Dossier ReviewMarket AuthorizationPharmaceutical ProductsMedical DevicesBiological Drugs+2

Central drugs laboratory(cdl), calcutta, india (the appellate laboratory & who collaborative centre)

Drug Analyst

May 1988 – Mar 1995 · 6 yrs 10 mos · Calcutta, INDIA

organized & performed routine analysis of API, reference Standard, Pharmaceutical formulations. Acquired analytical skills in instrumental analysis (HPLC, FTIR, GLC, DSC), Microbial assay techniques, drafting SOPs, Documentation on reference standards for drugs. Maintenance of slant agar broth of reference microbial strains and to cater to the pharmaceutical manufacturers and testing Laboratories.

Analytical TechniquesInstrumental AnalysisMicrobial Assay TechniquesDocumentation