Paul Benninger has twenty years of global Clinical and Bioanalytical research experience
in which the last 10 years have been in the pharmaceutical CRO sector. He has a
complete hands-on experience in over 600 Phase 1/BE/BA studies, and over 50 single-centre
Phase 2 and multi-centre Phase 3 clinical trials.
During the past 10 years he has grown a privately held full service CRO from 6 employees
to over 600 employees from Canada and US. Mr. Paul also has a significant regulatory
compliance experience with all major regulatory agencies including the FDA, EMEA,
TPD and ANVISA.He has been involved in numerous successful North American FDA and
TPD inspection as well as providing independent auditing services for Indian CROs.
In 2006 while under his leadership, Allied Research International was named one
of the 50 Best Managed Companies in Canada.
Kamal Shahani is an MBA, with over 21 years of experience in the field of healthcare,
pharma and clinical research industry. Before establishing Cliniminds and Mediminds,
he was heading an international CRO Allied Research International - Cetero, North
America in India and at the same time working with ARIâ€™s international operations
in United States and Canada and was directly involved in setting up the CRO and
central reference lab in Miami, Florida. He has also worked for Gribbles Pathology
Australia and Dr. Lal PathLabs on the senior management positions, and established
and managed over 15 nationally and internationally accredited laboratories. For
the last 4 years he has been involved in developing and managing international level
educational and training programs in the field of Clinical Research and other healthcare
management areas, and has established one of the largest and most reputed network
for clinical research education and training. He is also an international business
consultant and Director on the board of various international healthcare and clinical
research companies. He has been nominated on the Editorial Board of Journal for
Clinical Studies, published from U.K.
She is professional with more than 6 years of varied experience in pharmaceutical and clinical industry across clinical operations, project management, data handling, data cleaning, quality management, medical writing, Labeling documents and last but not the least-training and conducting workshops.
Pranjal began her career as a Clinical Project Assistant and has progressed as Clinical Research Associate and then Clinical Research Associate-II. She also worked as a medical writer and QC analyst. She has vast experience as trainer within varied roles carried out during her career.
As a medical Writer, she was associated with authoring, compiling, formatting and editing multiple IND ARs, PADERs and IBs. Involved in developing content for regulatory filings, ensuring quality of content, approving minor or routine submissions and meeting predetermined timelines for all submissions. She was actively involved in labeling activity and has been anchoring the entire labeling process in the role of a Labeling Operations Specialist. She served as the primary interface between the company and the clientâ€™s labeling team. Moreover, developed a strong understanding of regulatory processes, documents and associated workflows.In addition, achieved excellent writing and word-processing skills. She was associated in writing the master global response by conducting thorough literature search and in preparing a brief report by compiling all relevant searches on particular question/concern/issues related to companyâ€™s product by adhering companyâ€™s business rules.
She was authorize to Quality check the document particularly the labels (CDS, USPI/PLR, SPC, etc) and maintain the quality standard of the project before submitting the document to the client/s.She was also associated in preparing the HSA (Healthcare Sub-Saharan Africa) leaflets by conducting online searches from various available websites and by evaluating data with the help of medics.Pranjal has a passion for root cause analysis, improving the productivity, learning, training and delivering quality work. During her Clinical Operations career as Clinical Research Associate, She faced many audits with least or minimal observations thus, representing a good quality work. She worked on phase II and Phase III trials on different therapeutic areas viz., Oncology, psychiatry, Ortho, Cardiovascular, and Diabetes. She earned her Masterâ€™s in Clinical Research from Cranfield University, UK and Masters in Organic Chemistry from University of Pune, Maharashtra, India.
Geetha Sanjay has over 8 years of experience in the field of healthcare and clinical research industry in which the last 4 years has been in Clinical data management and analytics. She has been with reputed organizations like GSK Biologicals, SIRO Clinpharm Pvt. Ltd. and Ranbaxy Laboratories Limited having worked in Clinical data management.
She has worked on over 30 studies in Oncology and Vaccine based trials. She has been a part of the query management team and has successfully performed database audit and testing as a part of quality control.
Munarika is an experienced clinical research professional. She is Masters in Clincial Research and has also done Postgraduate Diploma in Pharmaceutical Business Management.
She has worked on several clinical trials including Phase 3 Multicentre, Open Label Parallel, Two Groups, Multi Arm, Randomized, Registration Clinical Study to Evaluate the Efficacy and Safety of Colesevelam Hydrochloride as Combination Therapy in Adult Indian Non Diabetic Patients with Primary Hyperlipidemia and Type II Diabetic patients with Primary Hyperlipidemiaâ€ under the supervision of Dr. Sumant Gupta and Dr. Chakrapani Bhardwaj.
She has also worked on WHO Project â€œPromotion of Rational Use of Drugsâ€.
An innovative Medical Doctor with Post Graduation in Pharmacology and more than 30+ years of experience in Clinical Medicine, Clinical Research, Pharmaco-vigilance and Regulatory affairs. Varied experience of 20 years in the Bio- Pharmaceutical Industry with reputed companies like Serum Institute Of India, Sanofi Pasteur, Aventis, Shanta Biotechnics, Serono, MBL, Crucell and interactions with WHO, Ministry of Health, DCGI, DBT, ICMR, IMA, IAP, OPPI, APACHE, APCRI.
Planned and completed over 100 clinical trials ranging from Pre-clinical, Phase1-4 and pharmaco-epidemiological studies. Possess exemplary skills in Regulatory affairs in India and fully updated on EU, US regulations. Have worked in Pharmaco-vigilance since 30 years with some interesting publications. Excellent Medical writing skills and Editorial experience with Indian Journal of Pharmacology. Over 60 publications in National & International Journals. Have actively published several product monographs, PILs and publications for public interest. Have been M.Pharm & Phd guide at University of Pune. Excellent Public speaking and Analytical skills. Widely travelled and have done clinical trials in 10 countries across the world. Proven track record in the health sciences field.
Mr. Hari Kumar, A mid-senior level executive with over 12+ years of progressive experience within the clinical research/GMP Industry, with specific expertise in Quality Assurance/Clinical Operations, Project Management, process development and Implementation, Consolidation/Integration of Operational Processes and the preparation of standard operating procedures to improve operational efficiency. Proven performance in project management with the delivery of desired results. He is Masters in Science and has worked for Novartis, ClinTec, Omnicare and Lotus Labs.
Dr. S. Karim, PhD Pharmaceutical Medicine, is a clinical research professional based in India with over Ten years experience in clinical research and five years experience in conducting quality assurance audits and assessments in India and China Quality Assurance Management and experience of a wide range of audit programmes worldwide including:
- Investigator Site Audits
- System Audits: Clinical Research, Medical Affairs
- Bioavailability (BA) I Bioequivalence (BE) Facility Audits (GCP & GLP)
- Vendor Evaluations
- Contract Research Organizations (CROs)
- Academic Research Organizations (AROs)
Dr. Sharma has worked in the area of Formulation Development and Regulatory affairs for more than 20 years in few top pharmaceutical companies like Cadila, Alembic, Core Healthcare, Claris, Marksans Pharma, Strides, Himalaya.
During this period , he developed several formulations & their Quality specifications for Domestic as well as Export markets covering various dosage forms like, Tablet, Capsules, Softgel capsules, Oral Powders, Liquid Orals, Gels, Injectables ( SVP/LVP including Oncology products, Parenteral Nutrition Products), dietary supplements ( Herbal formulations and Non-Herbal Formulations). He is well versed with the ICH, API/Bulk drug DMF, ANDA, CTD, ACTD, etc., the Technical specifications and quality testing parameters for Active Pharmaceutical ( Bulk Drugs), Finish Product, packaging materials, etc. During this tenure, he also developed several Novel formulations and filed patents for the same.
In the last 15 years, he has successfully got registered more than 500 various pharmaceutical formulations to various regulatory authorities across the world , including US, EU, Russia, RoW, etc. and was part of several international client/Regulatory Authority audits for product development, quality specifications.
He has also worked in Technology Transfer, Analytical Method transfer from R&D to other testing Laboratories of the World and presently working as Assistant Vice President â€“ New Product Development & Analytical Development with additional responsibilities of International Regulatory Affairs for Global Market including US, EU, RoW.
I have also been active trainer in the area of Basic Pharmacy for the Non-Pharmacy employees, ICH guidelines on Quality, Product Design & Development, cGMP, Dossier Preparation & Review.
Dr. Pandey is qualified medical doctor. 11 years of experience in managing Healthcare, Life sciences, Pharmacovigilance process transition, operations, client interaction.
At present setting up the Pharmacovigilance process at Certifiedpvpro and working on pharmacovigilance quality at CRQA.
Dr. Pandey has extensive experience with Accenture as Deputy Manager and iGATE as Team Manager â€“ Pharmacovigilance Operations. Worked as Domain expert/ SME â€“pharmacovigilance with Pfizer Inc. Her experience and skills includes :
- Expertise in handling client facing situations.
- Strong Project management and operations management skills.
- Strong knowledge in maintaining quality systems to ensure the quality of processes and deliverables of both projects and services meet the expectations as per regulatory requirements
- Validation lead for multiple projects.
- Trained in Argus 7.0 safety application.
- Knowledgeable in processes and tools pertaining to Pharmacovigilance (Argus, Aris G, Ag Exchange and CARES) based on COTS life cycle.
- Knowledgeable in various regulatory guidelines like ICH guidelines, Good Clinical Practices, Good Documentation Practices and Code of Federal Regulations, Volume 9A etc.
- Business Process development - Developed SOPs and SOW for the process
- Functional testing (OQ/PQ) for ArisG safety suite.
- Post execution QA lead for testing of PQ/OQ scripts of ArisG safety application and Ag Exchange suite.
- Extensive exposure in managing drug safety operations in leading IT companies.
- An effective communicator & competent subject matter expert with honed analytical, operational & organizational abilities.