CLINIMINDS brings to you an intensive course covering all the aspects of case processing, specially designed for Pharmacovigilance professional. Our training program involves: 1. Fresher training for Drug Safety Associate with Hands On experience on safety database 2. Training on Case Processing 3. Training on Aggregate Reporting with Hands On experience in PSUR/ PBRER writing 4. Training on Signal Detection and Risk Management 5. Training on Regulatory Affairs on Audits 6. Training Medical and Scientific Content Writing 7. Customized Training on Pharmacovigilance (Designed exclusively for Corporate who need domain knowledge on specific area (s) of pharmacovigilance)

1. Your Pharmacovigilance Training
Partner

2. Corporate Facts (Contd..)
Lineage:
 Cliniminds is a part of the Tenet Health Edutech family, a 12 year old
quality health sciences training and consulting firm which boasts of
state of the art training and extensive consulting experience with the
life sciences companies.

3. The Cliniminds Advantage
Client-centric Engagement Model
 Our deep-set commitment to our clients defines how we do business,
and the vast array of training services we offer. We build our teams
around your requirements, offering specialized services and solutions
that meet the distinct needs of your business.
 We believe in providing the right amount and quality of work at the
right cost at the right time.

4. The Cliniminds Advantage (contd..)
Experienced Team
 An eminent panel which possesses superior medical knowledge and
English writing skills to cater to global organizations as well as Indian
organizations. The staff are pre trained at our sister organization,
Cliniminds, an internationally accredited Pharmacovigilance training
organization. Entire team is GCP and GPV trained and certified.
 Team experienced on Oracle Argus Safety, ARISg, AB Cube and other
proprietary safety databases.

5. The Cliniminds advantage (contd..)
Quality as a way of life
 Cliniminds systems, infrastructure, processes, IT are successfully audited by
global auditors
Ethics and Compliance
 Use of tried and tested business practices
 Aim to cultivate and nurture long term relationships with all our stakeholders

6. IT Infrastructure & Data Security
Strong IT Systems, Servers & Processes
Well secured offices – physical and electronic security –
monitored 24x7
Internal server which is firewall protected
Round the clock monitoring to ensure security and
maintenance
Highest standards of data security measures are employed
Zero risk of data loss, pilferage or unauthorised access
24x7 power supply and power back ups

7. Quality Systems
 Cliniminds systems, infrastructure, processes, IT are successfully audited by
global auditors
 Internationally accepted, state of the art data handling systems
 Confidentiality agreements signed by all staff and vendors
 Cliniminds has well defined, detailed, validated, audited SOPs on all business
processes, services, IT, data security, administration, disaster management,
business continuity planning.

8. Corporate Training Programmes
 Cliniminds certified team of trainers ensures a focus on constant
training and retraining of its staff.
 Team Cliniminds is rich in experience, qualification and stability.
 We have a good pool of well trained and certified professionals with
medical, dental, life sciences and Pharmacy backgrounds.
 Cliniminds certifications are accredited by the ACCRE, USA. In addition,
Cliniminds is Student Chapter of Drug Information Association.

9. Pharmacovigilance Training
Cliniminds corporate pharmacovigilance programmes are designed to
provide comprehensive yet cost effective training solutions to the client
needs.
All programmes have been prepared in consultation with industry experts
and cater to the live industry scenarios.
Programmes can be delivered at the client site or in an online mode.
Suitable for beginners as well as mature PV companies.

10. Pharmacovigilance Training
Programs include :
 Customized eLearning modules
 Printed books
 Live or online interactive sessions
 Online assessments
 Session recordings
 Training records and MIS
 Certification

11. Pharmacovigilance Training
1. Understanding pharmacovigilance systems
◦ Regulations in Pharmacovigilance
◦ This section would cover international regulations and applicable local
regulations as per client requirements
◦ Setting up a pharmacovigilance system
◦ Qualified Person for Pharmacovigilance (QPPV) and their importance
2. Spontaneous case processing
◦ Receipt and handling of spontaneous reports including narrative writing
◦ Expeditable and non expeditable reports
◦ Medical Evaluation
◦ Quality Checks
◦ Electronic submissions

12. Pharmacovigilance Training
3. Handling study reports
◦ Introduction to clinical studies and receipt of study reports
◦ Handling solicited and clinical study reports
◦ Narrative Writing
◦ Medical review and SUSARs (SUAs)
◦ Investigator’s Brochures and their significance
◦ Blinded clinical trials- PV considerations
4. Literature search and review
◦ Regulations, Databases, review and case entry
◦ Aggregate reporting requirements
◦ Risk Benefit Assessment

13. Pharmacovigilance Training
5. Aggregate Reports
◦ Roles and responsibilities
◦ Types of aggregate reports
◦ Content and format
◦ Quality control and distribution
6. Signal detection, assessment and risk management plans
◦ General considerations
◦ Sources of signals
◦ Detection and assessment
◦ Risk assessment and minimization

14. Pharmacovigilance Training
7. Guidance documents in Pharmacovigilance
◦ Types of guidance documents
◦ Importance and scope of SOPs and WI’s
8. Reference Safety Information
◦ Types of RSIs
◦ Role and Importance
◦ Review of and updating RSIs
9. Pharmacovigilance Audits and Inspections
◦ Introduction and relevant guidance
◦ Audit preparations
◦ Audit findings and CAPA

15. Safety database solutions
Cliniminds partners with AB- Cube Solutions –France
AB Cube provides cloud based software solutions for vigilance in Human Drugs, Medical
Devices, Cosmetics, Nutraceuticals and veterinary products.
Cost effective
User friendly
Fully validated for quick, easy import, entry and electronic submissions of adverse events.

16. Key features of our safety solution
Unlimited number of users with one time
implementation cost.
Safety solutions are FDA 21CFR part 11, E2B (R3),
HL7 compliant
Validated according to GAMP 5 (Good automated
manufacturing practices), full validation dossier
provided.
Safety solutions are FDA 21CFR part 11, E2B (R3),
HL7 compliant
Generation of PBRER and Signal Detection.
Extensive support 24/7 & Training on database
through e- learning, virtual and Face to Face

17. Argus safety
Official tie up with Argus Safety for hands on training :
Case Entry / Book In / Case Triaging
Data Entry
Medical Review
Aggregate reporting (Line Listings , Summary tabulations)

18. Team
Our leadership team consists of experts from the field of pharmacovigilance
with experience in all major domains within pharmacovigilance, viz. case
processing, MedDRA coding, narrative writing, aggregate report writing,
signal detection, risk management, medical writing, safety databases.
Total 75+ man years of combined experience in their fields of expertise.

19. VISION
Our Team has
DEDICATION
EXPERTISE
CONTINUITY
QUALITY

20. It would be our pleasure to hear
from you
Business Development
Cliniminds
C-101, First Floor
Sector 2
NOIDA 201301
India
Email : info@cliniminds.com
Website : www.cliniminds.com
Phone : +91 98100 68241