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2 DAY WORKSHOP
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               CLINICAL TRIALS AUDITING AND
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Clinical Trials Auditing And Inspections January 16th & 17th, 2010

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I am now pleased to inform you that Cliniminds is organizing a two days Workshop on Clinical Trials Auditing & Inspections on 16 -17 January 2010 (Saturday & Sunday) in Bangalore.

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Clinical Trials Auditing And Inspections January 16th & 17th, 2010

  1. 1. 2 DAY WORKSHOP ON CLINICAL TRIALS AUDITING AND INSPECTIONS January 16th & 17th, 2010 BENGALURU Presented by cliniminds An ISO 9001:2000 Certified Academy CLINIMINDS WORKSHOP OBJECTIVE KEYNOTE SPEAKERS Cliniminds is an innovative clinical research Upon completion of the program, students would Paul Benninger academy providing a wide range of clinical be able to understand the basics concept of research training solutions to the students, quality assurance in clinical trials; process and Paul Benninger has twenty years of global pharmaceutical companies, CROs and implications of Audits & Regulatory inspections Clinical and Bioanalytical research healthcare companies in India and other and the issue of Frauds and misconduct. The experience; the last 10 years have been parts of the world. program is practical in nature and students in the pharmaceutical CRO sector which would be able to apply the knowledge in the has included full P&L responsibility for Cliniminds was established in year 2004, by work environment as well. business units in Canada (Toronto) and a group of professionals from Clinical the US (Miami). Successfully designed Research, Pharmaceutical industry and KEY ADVANTAGES OF THIS COURSE and led construction efforts for five Phase Healthcare industry with rich and varied 1 units in Canada, US and India for a experience at top levels. Company was set • Today, this profession is one of the most total of over 600 beds. Hands-on up with the objective to offer training reputed, compulsory and integral functions of experience in over 600 Phase 1/BE/BA solutions in the field of clinical research, clinical research. studies, over 50 single-centre Phase 2 pharmaceuticals and healthcare. Cliniminds and multi-centre Phase 3 clinical trials. today is one of the best clinical research During the past 10 years has grown a • ICH- GCP, Indian GCP guidelines and training academy offering worldclass privately held full service CRO from 6 regulations specify the requirement to have an workshops and corporate training programs employees to over 600 employees independent audit function. to Corporates and Individuals in India, USA, (Canada/US). Service offerings expanded U.K., Canada, Africa, Asia and Middle East. over the 10 years to include a full suite • Auditing in clinical research has evolved to be far more value-added to an organisation than of CRO services, such as Phase 1 studies THE WORKSHOP only assessing compliance with regulations. (First in Man, SAD, MAD, BA/BE), Bioanalytical Analysis, PK/PD, Statistics, • A career in auditing and Inspection provides an Medical Writing, Clinical Diagnostic Clinical Trials in India have increased exponentially in number over the last opportunity to understand the complete clinical Analysis, Data Management, Clinical decade. The increased business has brought development process from clinical development Monitoring and Late Stage Project into sharp focus the need to manage quality planning to the preparation of the registration Management. He has significant while conducting clinical trials. This workshop dossier. There are no other roles within research regulatory compliance experience with all is specifically designed for those involved in major regulatory agencies including the preparing for and overseeing GCP inspections and development that can offer this breadth of experience. FDA, EMEA, TPD and ANVISA. He has and those responsible for quality assurance and auditing in the industry. been involved in numerous successful • Audit focuses on compliance assessment, and North American FDA and TPD inspection WHO SHOULD ATTEND this is also an expectation of the regulatory as well as providing independent auditing authorities. services for Indian CROs. In 2006 while All Professionals who are either under his leadership, Allied Research International was named one of the 50 working or planning to with Indian • FDA inspections have been very few in India Best Managed Companies in Canada. investigational sites. All over the past 10 years but this is expected to increase exponentially over the next few years. Presently Paul is engaged in sharing his investigators & site personnel who knowledge of the industry as a private will face or have faced regulatory consultant. • India is involved in managing 15 to 20% of inspections. Freshers/ Experienced the global data management activity. Out of personnel who want to move into this, 1.5% data is of Indian origin. Quality of the Ashwani Pandita the field of Quality Assurance. work done from India therefore assumes high importance. Ashwani Pandita is working with Reliance TOPICS COVERED Life Sciences Pvt. Ltd. (RLS) as Deputy • A clinical auditor also acts as a consultant and Manager - Clinical Quality. He has Importance of Quality in Clinical Trials quality adviser to the functions involved in the obtained his Masters in Quality drug development process, providing 'trouble- Management from Birla Institute of shooting' advice and interpretation of regulations Technology and Science (BITS) Pilani, Difference between Quality Control and and guidelines with his Bachelor’s in Pharmacy from Quality Assurance Nagpur University. At RLS, he is the • Auditing is a people-orientated role and overall in-charge of quality assurance for Audits ( Sponsor and External)- Preparation therefore excellent written and verbal Clinical Trials. He has an experience of and Conduct communication skills are keys to success. more than 7 years in Quality Assurance. He has conducted several clinical trial Important Audit Findings in Clinical Research • An auditor interacts with a diverse range of audits till date including investigator site groups such as third party service providers, audits, vendor audits and system audits. Practical Sessions on Audits CRAs, Investigators, Study Nurses and other Additionally, he has an experience of study site personnel, and in the event of hosting several inspections including Regulatory Inspections: Definition, inspections the regulatory inspectors. USFDA inspections and EMEA inspections. Importance and NeedFDA Inspection ( Preparation and Conduct) SCHEDULE At RLS, Ashwani is also responsible for the training of clinical research staff on EMEA Inspection ( preparation and Conduct) 16th - 17th January 2010 (Saturday & Sunday) various aspects of clinical trials and GCP. 9AM - 5PM Ashwani has joined RLS in August 2005 Important Differences between FDA and and prior to joining RLS, he was EMEA inspection Process REGISTRATION FEE associated with the pharmaceutical companies like Cadila Pharmaceuticals, Regulatory Structure in India ( Schedule Y, Rs.12,500/- (Fee includes Lunch; Ipca Laboratories and US Vitamins. DCGI Responsibilities) beverages, workshop folder and certification) Dr. Naveen Tirkey DCGI Inspections Early bird Discount: Naveen is a Certified Clinical Research Types of EIRs- OAI, VAI, NAI, Warning 20% for Registrations before 12th December 09, Associate (CCRA) from Association of Letter 10% for Registrations before 31st December 09. Clinical Research Professionals (ACRP) and a pharmacologist (Ph.D.) by education Responding to Inspection reports PAYMENT MODE with broad experience (around 9 years) together in Clinical Research as well as Case Scenarios, Discussion on Practical academics for drug development By Cash or Bank Draft/Cheque favouring 'Tenet Findings processes. Specializing in the areas of Health Edutech Pvt. Ltd.' Sponsor liaising and budget negotiations, clinical study set up (Phase I-IV), Project CERTIFICATE Management, Training of CRAs with co- monitoring visits, SOPs creation, Medical Certificates of Participation will be issued to all Writing, GCP-Audits of sites and vendor participants. management. Managed various Program is certified & Accredited by the international and multicenteric oncological Pharmaceutical Society of India. projects. In his current position he is the Manager- QA (Clinical Trials) at Veeda Oncology (VON) and is responsible for formulating training strategies for operations team. He also assists in the establishment of systems and procedures for quality assurance of VON in coordination with the global QA and manages all the standard operating procedures (SOPs) as well as WIs/Forms and Templates for Clinical Trials conducted by VON. Deepti Goel Deepti Goel has over 9 years of experience in clinical research working with Pharma companies, CRO and training academy. By Training, she is an M.Pharm with specialization in Pharmacology. She has worked across various clinical research verticals including clinical operations, quality assurance and training. She has monitored, managed projects, mentored teams and trained clinical research professionals. She has been instrumental in setting up a QA and Training unit in one of the pharma companies in the past. As a monitor she has prepared many sites for inspections and faced many external audits. As an auditor, she has carried various types of audits at the sites, CROs and Central labs. She has conducted various training programmes for internal team as well as corporates on Basic and advanced GCP and related issues. In her current assignment she is the Head of Training and Operations at Cliniminds and is responsible for oversight of operations and training needs and development across India. Limited seats available, Book soon to avoid disappointment For Registration & Information, Please Contact Deepika: +91-9945114511 Manasa: +91-96636-91388 deepika@cliniminds.com manasa@cliniminds.com Bangalore No. 420, 1st Floor, 9th Main, Banashankari 2nd Stage, Bangalore - 560070 www.cliniminds.com | Delhi | Bangalore | Cochin | Hyderabad | Bhopal | Europe |

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