Name: Dr. Aditi Pusalkar Apte
Qualifications: MBBS, MD Pharmacology.
Area of expertise: Clinical Research, Pharmacovigilance.
Current profile: Research Consultant, KEM Hospital Research Centre, Pune. She has an experience of around a decade in the area of clinical research. Dr. Aditi is a proficient trainer and an expert in medical review.
Name: Dr. Shraddha Bhange
Qualifications: MBBS, MBA (HM), M.Sc. Biomedical Technology
Areas of Expertise: Content writing, quality assurance, signal detection and signal
evaluation activities for assigned products, development of safety reports
& risk management plan, internal audits, health authority inspection.
Current profile:Pharmacovigilance expert at Novartis Healthcare Private Limited. She is on editorial board of International Journal of Clinical Trials. A self-motivated leader represented Health and Life Science faculty in the Coventry University, UK. She is a proactive blogger on topics related to medicines.
Name: Dr. Ganesh Uchit
Qualifications: MBBS, MD (Clinical Pharmacology)
Areas of Expertise: Protocol development, expertise in women’s health, urology, critical care, neuroscience and more.
Current Profile: Therapy Lead, medical division of Pfizer. He is an accomplished trainer on topics of Good Clinical Practices guidelines and.regulatory processes at global level. He worked in regional center for “National Pharmacovigilance Program” of India for three years. A hard-core academician; has seven publications in different journals.
Name: Dr. Srikanth J V
Designation: Cognizant Technology Solutions in Medical Safety Activit
Areas of Expertise: Training in the area of clinical research, safety surveillance, content writer; medical reports. Acclaimed for international training session on authoring aggregate reports and risk management plans.
Associated with Cognizant Technology Solutions. Successful entrepreneur; runs efficiently his own KPO.
Name: Dr. Ujwala Rajeev Naik
Areas of Expertise: Extensive experience of 12 years in the area of medical review of ICSRs, PSURs, PADERs and in signal detection, aggregate report writing, causality assessment, clinical trial protocol review. Expert in regulations of pharmacovigilance and ICH guidelines and has implemented the same in various profiles
Current Profile: Cross Sector Country Safety Head-India Cluster Johnson and Johnson Consumer and Pharma division. She confidently leads Cross Sector safety team that includes pharmaceuticals as well as consumer product portfolio. She is an energetic member of Maharashtra Medical Council and Indian Society of Clinical Research.
Dr. Milind Sardesai
Qualifications:MBBS, MHSc, PGDCR
Areas of Expertise: Having over 16 years of experience in pharmaceutical companies and CROs. Expertise involved medical writing, pharmacovigilance, medical affairs and business operations.
Current Profile: Currently he is working, as General Manager Operations, Cognizant Technology Solutions. Dr. Milind Sardesai is involved in monitoring the safety of globally marketed products, as well as products in development phases. He has gained hands on experience in case processing, aggregate reporting (DSUR,PSUR, PBRER), signal detection (Qualitative & Quantitative) and risk management (RMP & Updates) within the domain of pharmacovigilance. Apart from delivering presentations in various national and international fore, he has extensively contributed in authoring complex clinical and medical documents for global clinical submissions and marketing support.
Name: Dr. Madhura Nene
Areas of Expertise: Clinical research, HIV/AIDS, Tuberculosis.
Current Profile: She is an independent consultant, on different clinical research projects and is based in Pune, India. In her stint of six years, she epitomized her leadership qualities in the capacity of ‘Research Physician’ on various national and international projects at National AIDS Research Institute (ICMR). She was director, Quintiles, medical data review and played a pivotal role in establishing the department at a reputed clinical research industry. She has successfully led clinical trials, post-marketing programs, focusing on drug safety and medical data review across different therapeutic areas.
Name: Garun Yadav
Qualifications: MBA in Healthcare Management, PGDCR
Areas of Expertise: Clinical data management, proficient in niche areas of document creation, user acceptance testing, database testing, SAE reconciliation, query management and more.
Current Profile: Assistant Manager-CDM at Inventive International Pharma Services Pvt. Ltd., Pune, India. An excellant team leader, he has proven abilities of bridging performance gaps to complete buisness interest, developing process improvement initiatives and translating complex concepts to simpler form. Mr. Yadav has experience in theuapeutic areas such as oncology, hematology, infant nutrition along with recruitments, budgeting, human resource management. He has been recognised with many awards in most of the organizations worked so far for his contributions.
Name: Dr. Naveen Chhabra
Qualifications: MBBS, MD (Pharmacology)
Areas of Expertise: A gold medalist physician with an extensive experience in clinical trials and pharmacovigilance authored and reviewed aggregate safety reports. He has expertise in core areas includes training, ICH-GCP guidelines, medical writing, designing risk management plans.
Current Profile: He is holding position of Lead- Medical Reviewer at Cognizant Technology Solutions. Having excellent communication skills, he has proven his ability to work within regulatory & client specified framework. He has mentored many aspirants to achieve excellence in medical writing.
Dr. Chhabra has several publications to his credit in national and international journals.
Name: Dr. Purushottam Surti
Qualifications: MBBS, PGDBM
Areas of Expertise: Clinical research, Data management, Biostatistics and Programming
Current Profile: Director, Clinical Data Management at Oncorx Pharma Pvt Ltd (a subsidiary of Spectrum Pharmaceuticals, USA) he is having key role in development of several molecules. He has an extensive experience of around two decades in the industry.
Name: Mr. Sandeep Haldankar
Qualifications: BSc (Statistics)
Areas of Expertise: Clinical data management, programming in clinical trials, web based technologies, data management software applications. He is competent in therapeutic areas like cardiovascular, dermatology, and oncology to name a few.
Current Profile: He holds position of Associate Director, Clinical Data Management Programming at inVentiv Health Clinical. He is skilled in project and resource management. Having excellent communication & leadership skills, he was successful established clinical data management unit in the pharma Net India Office.
Name: Dr. Priti Kalel
Qualifications: BAMS, Advance Diploma in Clinical Research, Pharmacovigilance, Clinical Data Management.
Areas of Expertise: Pharmacovigilance and Clinical Data Management, ICH-GCP guidelines.
Dr. Kalel has been part of quality review & quality control processes at Quintiles.
Current Profile: Presently, Dr. Priti is Asst. Medical Data Review Manager, Quintiles Technology (India) Pvt Ltd. Her expertise includes analysis of the clinical trial data. She has played a key role in various study report generation such as query detail report, data status report and others.
Name: Ramkrishnan Nellaiappan
Qualifications: M.S. Biomedical Engineering, MBA Project Management
Areas of Expertise: Clinical research, data management, project management, business development, therapeutic areas such as - Oncology, Neuroscience, Cardiovascular, Immunology and more.
Current Profile: Currently he is holding position of Associate Director, CDM & SDTM / IDB & PKPD SAS programming inVentive Health Pune. With a stint of 13 years of experience in reputed ten pharma companies? He is proficient in drug discovery research in academia/CRO/pharmaceutical/biotech settings. Ramkrishnan is equipped with competencies in operating different clinical data management softwares and statistical programming. He is been certified by Six Sigma Green Belt (quality management methods) by KPMG (professional service company).
Qualifications: MCA, University of Madras
Areas of Expertise: Data management in clinical research, development and operations of softwares and clinical data processing.
Current Profile: Currently, working as Senior Programmer, in Clinical Data Management Centre (CDMC) Department of Biostatistics, Christian Medical College & Hospital, Vellore, Tamil Nadu,India.
A senior professional, has significant experience of around 16 years with proven records of accomplishment in undertaking multitasking roles as a co-investigator, trainer, content writer, implementer of data management integrity in reputed organizations. Presently, he is efficaciously leading ten research projects under his able guidance at a reputed medical college of India. He is a renowned resource person and have represented in various workshops and training programs in the area of clinical research. An intuitive academician has many publications in national and international journals on his credit.
Name: Dr. Avinash Khairnar
Educational Qualifications: M. Pharma (Pharmacology), PhD (Medical Pharmacology)
Areas of Expertise: Clinical Research, Pharmacovigilance, Pharmacoepidemiology
Current Profile: He is working as Associate Professor and Head, Department of Pharmacology in the SMBT Dental College, Sangamner,
Maharashtra. A multi dynamic teacher, researcher, evaluator in the field of pharmacovigilance for more than 10 years. He has successfully completed around 80 projects
in the area of Pharmacoepidemiology and has several publications on “Drug Safety” to his credit. He is a founder member of the first MSc. “Pharmaceutical Medicine” course in India.
He has trained more than 600 personnel in the domains of;
ICH GCP guidelines, protocol writing, and research methods & statistics