2 DAY WORKSHOP ON

CLINICAL TRIALS AUDITING ANDINSPECTIONS

January 16th & 17th, 2010BENGALURU

Presented by

clinimindsAn ISO 9001:2000 Certified Academy

CLINIMINDS

Cliniminds is an innovative clinical researchacademy providing a wide range of clinicalresearch training solutions to the students,pharmaceutical companies, CROs andhealthcare companies in India and otherparts of the world.

Cliniminds was established in year 2004, bya group of professionals from ClinicalResearch, Pharmaceutical industry andHealthcare industry with rich and variedexperience at top levels. Company was setup with the objective to offer trainingsolutions in the field of clinical research,pharmaceuticals and healthcare. Clinimindstoday is one of the best clinical researchtraining academy offering worldclassworkshops and corporate training programsto Corporates and Individuals in India, USA,U.K., Canada, Africa, Asia and Middle East.

THE WORKSHOP

Clinical Trials in India have increasedexponentially in number over the lastdecade. The increased business has broughtinto sharp focus the need to manage qualitywhile conducting clinical trials. This workshopis specifically designed for those involved inpreparing for and overseeing GCP inspectionsand those responsible for quality assuranceand auditing in the industry.

WHO SHOULD ATTEND

All Professionals who are eitherworking or planning to with Indianinvestigational sites. Allinvestigators & site personnel whowill face or have faced regulatoryinspections. Freshers/ Experiencedpersonnel who want to move intothe field of Quality Assurance.

TOPICS COVERED

Importance of Quality in Clinical Trials

Difference between Quality Control andQuality Assurance

Audits ( Sponsor and External)- Preparationand Conduct

Important Audit Findings in Clinical Research

Practical Sessions on Audits

Regulatory Inspections: Definition,Importance and NeedFDA Inspection (Preparation and Conduct)

EMEA Inspection ( preparation and Conduct)

Important Differences between FDA andEMEA inspection Process

Regulatory Structure in India ( Schedule Y,DCGI Responsibilities)

DCGI Inspections

Types of EIRs- OAI, VAI, NAI, WarningLetter

Responding to Inspection reports

Case Scenarios, Discussion on PracticalFindings

WORKSHOP OBJECTIVE

Upon completion of the program, students wouldbe able to understand the basics concept ofquality assurance in clinical trials; process andimplications of Audits & Regulatory inspectionsand the issue of Frauds and misconduct. Theprogram is practical in nature and studentswould be able to apply the knowledge in thework environment as well.

KEY ADVANTAGES OF THIS COURSE

• Today, this profession is one of the mostreputed, compulsory and integral functions ofclinical research.

• ICH- GCP, Indian GCP guidelines andregulations specify the requirement to have anindependent audit function.

• Auditing in clinical research has evolved to befar more value-added to an organisation thanonly assessing compliance with regulations.

• A career in auditing and Inspection provides anopportunity to understand the complete clinicaldevelopment process from clinical developmentplanning to the preparation of the registrationdossier. There are no other roles within researchand development that can offer this breadth ofexperience.

• Audit focuses on compliance assessment, andthis is also an expectation of the regulatoryauthorities.

• FDA inspections have been very few in Indiaover the past 10 years but this is expected toincrease exponentially over the next few years.

• India is involved in managing 15 to 20% ofthe global data management activity. Out ofthis, 1.5% data is of Indian origin. Quality of thework done from India therefore assumes highimportance.

• A clinical auditor also acts as a consultant andquality adviser to the functions involved in thedrug development process, providing 'trouble-shooting' advice and interpretation of regulationsand guidelines

• Auditing is a people-orientated role andtherefore excellent written and verbalcommunication skills are keys to success.

• An auditor interacts with a diverse range ofgroups such as third party service providers,CRAs, Investigators, Study Nurses and otherstudy site personnel, and in the event ofinspections the regulatory inspectors.

SCHEDULE

16th - 17th January 2010 (Saturday & Sunday)9AM - 5PM

REGISTRATION FEE

Rs.12,500/- (Fee includes Lunch;beverages, workshop folder andcertification)

Early bird Discount: 20% for Registrations before 12th December 09,10% for Registrations before 31st December 09.

PAYMENT MODE

By Cash or Bank Draft/Cheque favouring 'TenetHealth Edutech Pvt. Ltd.'

CERTIFICATE

Certificates of Participation will be issued to allparticipants.Program is certified & Accredited by thePharmaceutical Society of India.

KEYNOTE SPEAKERS

Paul Benninger

Paul Benninger has twenty years of globalClinical and Bioanalytical researchexperience; the last 10 years have beenin the pharmaceutical CRO sector whichhas included full P&L responsibility forbusiness units in Canada (Toronto) andthe US (Miami). Successfully designedand led construction efforts for five Phase1 units in Canada, US and India for atotal of over 600 beds. Hands-onexperience in over 600 Phase 1/BE/BAstudies, over 50 single-centre Phase 2and multi-centre Phase 3 clinical trials.During the past 10 years has grown aprivately held full service CRO from 6employees to over 600 employees(Canada/US). Service offerings expandedover the 10 years to include a full suiteof CRO services, such as Phase 1 studies(First in Man, SAD, MAD, BA/BE),Bioanalytical Analysis, PK/PD, Statistics,Medical Writing, Clinical DiagnosticAnalysis, Data Management, ClinicalMonitoring and Late Stage ProjectManagement. He has significantregulatory compliance experience with allmajor regulatory agencies including theFDA, EMEA, TPD and ANVISA. He hasbeen involved in numerous successfulNorth American FDA and TPD inspectionas well as providing independent auditingservices for Indian CROs. In 2006 whileunder his leadership, Allied ResearchInternational was named one of the 50Best Managed Companies in Canada.Presently Paul is engaged in sharing hisknowledge of the industry as a privateconsultant.

Ashwani Pandita

Ashwani Pandita is working with RelianceLife Sciences Pvt. Ltd. (RLS) as DeputyManager - Clinical Quality. He hasobtained his Masters in QualityManagement from Birla Institute ofTechnology and Science (BITS) Pilani,with his Bachelor’s in Pharmacy fromNagpur University. At RLS, he is theoverall in-charge of quality assurance forClinical Trials. He has an experience ofmore than 7 years in Quality Assurance.He has conducted several clinical trialaudits till date including investigator siteaudits, vendor audits and system audits.Additionally, he has an experience ofhosting several inspections includingUSFDA inspections and EMEA inspections.

At RLS, Ashwani is also responsible forthe training of clinical research staff onvarious aspects of clinical trials and GCP.

Ashwani has joined RLS in August 2005and prior to joining RLS, he wasassociated with the pharmaceuticalcompanies like Cadila Pharmaceuticals,Ipca Laboratories and US Vitamins.

Dr. Naveen Tirkey

Naveen is a Certified Clinical ResearchAssociate (CCRA) from Association ofClinical Research Professionals (ACRP) anda pharmacologist (Ph.D.) by educationwith broad experience (around 9 years)together in Clinical Research as well asacademics for drug developmentprocesses. Specializing in the areas ofSponsor liaising and budget negotiations,clinical study set up (Phase I-IV), ProjectManagement, Training of CRAs with co-monitoring visits, SOPs creation, MedicalWriting, GCP-Audits of sites and vendormanagement. Managed variousinternational and multicenteric oncologicalprojects.

In his current position he is the Manager-QA (Clinical Trials) at Veeda Oncology(VON) and is responsible for formulatingtraining strategies for operations team.He also assists in the establishment ofsystems and procedures for qualityassurance of VON in coordination withthe global QA and manages all thestandard operating procedures (SOPs) aswell as WIs/Forms and Templates forClinical Trials conducted by VON.

Deepti Goel

Deepti Goel has over 9 years ofexperience in clinical research workingwith Pharma companies, CRO and trainingacademy. By Training, she is an M.Pharmwith specialization in Pharmacology. Shehas worked across various clinicalresearch verticals including clinicaloperations, quality assurance andtraining. She has monitored, managedprojects, mentored teams and trainedclinical research professionals. She hasbeen instrumental in setting up a QA andTraining unit in one of the pharmacompanies in the past. As a monitor shehas prepared many sites for inspectionsand faced many external audits. As anauditor, she has carried various types ofaudits at the sites, CROs and Centrallabs. She has conducted various trainingprogrammes for internal team as well ascorporates on Basic and advanced GCPand related issues.

In her current assignment she is theHead of Training and Operations atCliniminds and is responsible for oversightof operations and training needs anddevelopment across India.

Limited seats available, Book soon to avoid disappointment

For Registration & Information, Please ContactDeepika: +91-9945114511deepika@cliniminds.com

Manasa: +91-96636-91388manasa@cliniminds.com

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