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.

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 |