Dr. Manjunath A S Email & Phone Number

Ahmedabad Area, India

Ahmedabad Area, India

 Complete design and Conduct of Bioequivalence studies. Directly experienced in design, safety and conduct of following types of studies:o Pharmacodynamic equivalence studies, Therapeutic non-inferiority studies.o Bioequivalence studies in Patients from Hospitals.o Trans-dermal products such as Patches, Ointments.o Injectables, Solutions, Suspensionso Studies in special populations like elderly, Post-menopausal women, obese populations. Complete responsible of… Show more  Complete design and Conduct of Bioequivalence studies. Directly experienced in design, safety and conduct of following types of studies:o Pharmacodynamic equivalence studies, Therapeutic non-inferiority studies.o Bioequivalence studies in Patients from Hospitals.o Trans-dermal products such as Patches, Ointments.o Injectables, Solutions, Suspensionso Studies in special populations like elderly, Post-menopausal women, obese populations. Complete responsible of International Regulatory inspections of Ahmedabad Bioequivalence facility. Responsible for periodic staff training in GCP, revised regulatory guidelines. Responsible for forming cross-functional teams and training. Trainer to Project Managers, QA and CRA team in Clinical Trial Procedures such as Site selection, establishment and qualification, Site Iniation procedures, Data Quiery management, Medical safety reporting and Management of SAEs, Site close-out procedures. As a team Manager, staff recruitment, training and utilization, Vendor selections, Clinical studies Facility Management, Studies slotting, Client Timelines, Subject and Volunteer related aspects, Centralized teams like supply chain management and HR. Direct experience of International Client qualification audits, technical discussions and project awarding. Direct experience of answering regulatory queries from regulatory inspections, sponsor dossier review, and GCP audits by sponsor. Show less

Bengaluru Area, India

 Principal Investigator in more than 150 FDA, EMEA, DCGI and other submission studies Responsible for conduct of GCP compliant clinical research  Responsible for Safety Monitoring of trial subjects., Reporting Adverse Events and Serious Adverse Events to Sponsors and Regulatory Authorities  Review and responding to all QA, Sponsor and Regulatory queries pertaining to Clinical studies  Knowledge of European Pharmacovigilance guidelines, adverse events reporting, case entry,… Show more  Principal Investigator in more than 150 FDA, EMEA, DCGI and other submission studies Responsible for conduct of GCP compliant clinical research  Responsible for Safety Monitoring of trial subjects., Reporting Adverse Events and Serious Adverse Events to Sponsors and Regulatory Authorities  Review and responding to all QA, Sponsor and Regulatory queries pertaining to Clinical studies  Knowledge of European Pharmacovigilance guidelines, adverse events reporting, case entry, MedDRA coding, medical review Responsible for leading a team of more than 60 clinic staff through daily conduct of BA and BE studies. The team is involved every day in preparation and review of clinical study protocols, obtaining Ethics clearance, recruiting volunteers through registration, screening, Assessing suitability of volunteers for a specific study, Consent procedure, enrollment, dosing, and safety monitoring and study reporting. Directly responsible for Practice, implementation, Review and updating of clinic ethical and quality procedures such as SOPs, Work instructions specific for projects etc. Responsible for training clinic staff in clinic systems. Responsible for integration of Quality Assurance, Clinic, Administration, HR, Finance with management for meaningful outcomes. Show less

Bengaluru Area, India

Bioequivalence

Bachelor Of Medicine, Bachelor Of Surgery, Mbbs

Education record