clinimindsAcademy for Clinical Research Training & Management

An ISO 9001:2000 Certified Academy

TM

CLINIMINDS

Cliniminds is an innovative clinical research academy providing a widest range of clinical research training solutions to the pharmaceutical companies, CROs, healthcare companies and students globally. Cliniminds was established in year 2004, by a group of professionals from Clinical Research, Pharmaceutical industry and Healthcare industry with rich and varied experience at top levels. Cliniminds today is one of the most prestigious institutions offering world-class workshops and corporate training solutions in India, USA, U.K., Canada, Africa, Asia and Middle East. Cliniminds programs are accredited by several Indian and international agencies. Cliniminds’ client list includes NIH, US Government, Merck, Novartis, Quintiles and several other global and Indian companies.

THE WORKSHOP

Clinical Trials in India have increased exponentially in number over the last decade. The increased business has brought into sharp focus the need to manage quality while conducting clinical trials. This workshop is specifically designed for those involved in preparing for and overseeing GCP inspections and those responsible for quality assurance and auditing in the industry.

WHO SHOULD ATTEND

All Professionals who are either working or planning to work in Clinical Research Industry. All investigators & site personnel who will face or have faced regulatory inspections. Fresher / Experienced personnel who want to move into the field of Quality Assurance

KEY ADVANTAGES OF THIS COURSE

SCHEDULE

PAYMENT MODE

REGISTRATION FEE

Ÿ Today, this profession is one of the most reputed, compulsory and integral functions of clinical research.

Ÿ ICH-GCP, Indian GCP guidelines and regulations specify the requirement to have an independent audit function.

Ÿ Auditing in clinical research has evolved to be far more value added to an organization than only assessing compliance with regulations.

Ÿ There are no other roles like auditing and inspection within research and development that can offer this breadth of experience.

Ÿ Audit focuses on compliance assessment, and this is also an expectation of the regulatory authorities.

Ÿ International and local inspections have been very few in India over the past 10 years but this is expected to increase exponentially over the next few years.

Ÿ An auditor interacts with a diverse range of groups such as third party service providers, CRAs, Investigators, Study Nurses and other study site personnel, and in the event of inspections the regulatory inspectors.

12 -13 February 2011 (Saturday & Sunday) 9AM - 5PM

By Cash or Bank Draft / Cheque favoring 'Tenet Health Edutech Pvt. Ltd.’ at Delhi

Rs. 7,500/- (Fee includes Lunch, snacks, beverages, workshop folder and certification)

TOPICS COVERED

Ÿ Importance of Quality in Clinical Trials

Ÿ Audits ( Sponsor and External ) - Preparation and Conduct

Ÿ Important Audit Findings in Clinical Research

Ÿ Practical Sessions on Audits

Ÿ Regulatory Inspections: An Overview for FDA Inspection (Preparation and Conduct)

Ÿ EMEA Inspection (Preparation and Conduct)

Ÿ DCGI Inspections (Preparation and Conduct)

Ÿ Responding to Inspection Reports

Ÿ Preparing & Facing Pharmacovigilance Audits

Ÿ Case Scenarios, Discussion on Practical Findings

Ÿ Quiz Competition

FACULTY

Leading experts from the Clinical Research, Pharmacovigilance, Quality Assurance field with extensive QA experience. These experts would provide you with in depth hands on knowledge on the subject.

CERTIFICATE

Certificates of participation will be issued to all participants. Program is Accredited by SwAPP Switzerland.

A 2 DAY WORKSHOP ONCLINICAL TRIALS AUDITING AND INSPECTIONS

12 - 13 February 2011Ahmedabad

For Registration & Information Please ContactCliniminds Delhi -C-55 First Floor, Vikas Marg, Preet Vihar, Delhi-110092Contact: Email : ; Website:

+91-9313305556,+91-9313305581,+91-9810068241info@cliniminds.com www.cliniminds.com

DISCOUNT

10% for Registration before 31st January 2011. *Limited seats available, Book soon to avoid disappointment

Registration Form

Registration details :

Ÿ The workshop fees is INR 7,500 per person inclusive of all taxes.Ÿ The above cost includes workshop study material, morning and evening tea and snacks, lunch.Ÿ Registration fee is non-refundable and non-adjustable with other cliniminds programs. Ÿ Corporate Group Discount of 20% on 5 participants and above, and 25% discount for students.

Nomination Details

Name : _______________________________________________________________________________ Address : _____________________________________________________________________________

Designation : ___________________________ Email : ___________________________________

Telephone : ____________________________ Mobile : __________________________________

Name & Address of Organization : ._________________________________________________________

Exact name & title you would like to appear on certificate:

_____________________________________________________________________________________

Enclosed is the DD/Cheque No. _____________________ for INR _______________________ in favor of

“Tenet Health Edutech Pvt. Ltd.” payable at Delhi. Please send the DD/Cheque to ( You can also pay by Credit / Debit Card / Bank Transfer )

CLINIMINDS DELHIC-55, First Floor, Main Vikas Marg, Preet Vihar, Delhi-110092 (India)Tel:011-30287800 Fax:011-30287802

Date:______________

Place: _____________ Signature:____________

For Registration & Information Please ContactCliniminds Delhi -C-55 First Floor, Vikas Marg, Preet Vihar, Delhi-110092

Contact: Email: ; Website:

08527014678, +91-9910906014, +91-9810068241info@cliniminds.com www.cliniminds.com

clinimindsAcademy for Clinical Research Training & Management

An ISO 9001:2000 Certified Academy

TM