4. Our Milestones 2010: VAC3 Clinical Services was established in February 2010 2010: By Mid of 2010, VAC3 established an Expert panel consisting of people from countries like India, USA, The Netherland and Australia. 2010: By September 2010, VAC3 started following services a) Medical writing b) Medico Marketing c) Consultation
29. Content Search and WritingNewsletter and E-Zines Journal Digest Promotional Inputs Patient Education Brochure Poster Product Monograph Visual Aids Case Studies Manuscript Training Modules
36. Our Experts Jeroen de Neijs, MSc, The Netherland He has more than 10 years experience in clinical monitoring and project management. He has been involved in setting up clinical trials in pharmaceuticals and devices in the Netherlands, Belgium and Germany ranging from phase I to IV. His therapeutic experience is in setting up clinical trials includes hematology, cardiology, gastroenterology, infectious disease and rheumatology. Dr Susan Alder, MBBS, PhD & Jane Campbell-Higgins, MPH, Australia Dr Susan Alder and Jane Campbell-Higgins collectively have more than 50 years experience working in Pharmaceutical and Medical Technology Companies; Government (Australia and Singapore); Clinical Laboratories; Hospitals; and Education. Both hold the Certificate IV in Training & Assessment and have worked with organizations to provide training and assist change management, process improvement, systems development, and strategic planning. Together they have held every role involved in a clinical trial - from Investigator, CRA, Project Manager, and Auditor, right through to Clinical Operations Manager, Medical Director and Regulator.
37. Events Done Seminar on “Molecule to Medicine - Drug Development & Regulatory Processes” on 18th September, 2010 at Ahmedabad. Topics Covered Basic Concepts of New Drug Development: Scientific, Regulatory and Management framework. Clinical Phases in Drug Development and its rationale Investigation New Drug (IND) and New Drug Application (NDA) Process Regulatory Interaction, Application and Approval process Designing optimal clinical trial Drug labeling, Marketing and Pharmacoeconomics
38. Events Done Seminar on “Ethics in Clinical Research and Clinical Development” on 22nd May, 2010 at Ahmedabad. Topics Covered Ethics Committee- Role, Composition and Responsibilities Informed Consent Process Clinical Development in Elderly Clinical Development in Children Use of Placebo in Clinical Development Ethical Issues in gene Therapy
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