Pharmacovigilance
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ACCREDITED CONSULTANTS PVT LTD. (ACPL) WELCOMES YOU Your PHARMACOVIGILANCE PARTNER
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Transcript of Pharmacovigilance
ACCREDITED CONSULTANTS PVT LTD. (ACPL)
ACCREDITED CONSULTANTS PVT LTD. (ACPL)
WELCOMES YOU
Your PHARMACOVIGILANCE PARTNER
www.acplgroupindia.co.in
Pharmacovigilance is concerned with identifying the hazards associated with pharmaceutical products and with minimizing the risk of any harm that may come to patients.
As per new legislation, MAH should be responsible for continuously monitoring the safety of its medicinal products for human use.
www.acplgroupindia.co.in
ACPL is the leading Pharmacovigilance service provider in India.
We provide a wide range of pharmacovigilanceconsultative services to various pharmaceutical companies across the world.
www.acplgroupindia.co.in
Our Aim & GoalAdhere the regulatory standards and maintain the compliance which helps to
Improve Patient Care
Improve Public Health
Risk Benefit Assessment of medicine
effective communication to health
professionals & the public
www.acplgroupindia.co.in
Consulting Services that meet your needs
www.acplgroupindia.co.in
ACPL provides a wide range of pharmacovigilance services
Management of case reports and adverse event reporting
Individual Case Safety Report (ICSRs) Processing
Post‐Marketing Solicited and Spontaneous Reports
Clinical trial Reports.
Special Reports: Pregnancy reports etc.
Medical Device related Reports
Social media mining
Literature Reports
www.acplgroupindia.co.in
Aggregate/Periodic Report Writing & Submission
Aggregate & Periodic Report Writing reports (PSURs/PBRERs/PADERs, DSURs)
Addendum reports
Bridge reports
Annual safety reports etc. These reports are prepared in the proper format with appropriate content and submitted to the relevant regulatory authorities within compliant timelines.
www.acplgroupindia.co.in
Routine Safety Surveillance, Signal Detection & Management
Collection of ICSRs from database
Data cleaning & duplicate detection Signal interpretation (by quantitative or statistical methods)
Assessment for signalsRecommendation for action (including label update analysis and physician review)
www.acplgroupindia.co.in
Risk Management Plans (RMPs)
Risk-benefit management and analysis: ACPL provides strategic advice and analysis to develop updates risk management plans.
www.acplgroupindia.co.in
Why ACPL?Our team of dedicated drug safety and educational professionals offer our clients superior service and programs.
A compliance and client-oriented mindset to deliver quality within time.
World class, robust and refined technical infrastructure.
Exclusively, global drug safety service provider.
Last but not the least, we provide excellent quality services at highly competitive prices
www.acplgroupindia.co.in
ACCREDITED CONSULTANTS PVT. LTD. (ACPL)ACCREDITED CONSULTANTS PVT. LTD. (ACPL)
Contact Details:
Accredited Consultants Private Limited,D-29, First Floor, Acharya Niketan, Mayur Vihar Phase-I, Delhi-110091. Ph: 011-22758204, (M) +91-9310040434, +91-9266665201 Fax: 011-22758994
Email: [email protected]@acplgroupindia.co.in [email protected]: www.apclgroupindia.comwww.apclgroupindia.co.in
