ACCREDITED CONSULTANTS PVT LTD. (ACPL) WELCOMES YOU Your PHARMACOVIGILANCE PARTNER.

Slides:

Advertisements

Similar presentations

Mary Ellen Turner MD, MPH Vice-President

Advertisements

Overview of Risk management: A EU perspective Lincoln Tsang May 2008.

Common/shared responsibilities between jobs.

Pharmacovigilance by Dr. Notghi Contract Research.

Hoe gaat de overheid hiermee om? Wat zijn de overwegingen? Wanneer wordt bijv. besloten tot verkorting van de PSUR cycle.

Medsafe – GMP update / release for supply / communicating quality issues Derek Fitzgerald Manager, Compliance Management 11 July 2013 RACI Pharmaceutical.

1 Proposed Pharmacovigilance Plan for H5N1 Influenza Virus Vaccine Patrick Caubel, MD, PhD Head of Pharmacovigilance North America February 27, 2007.

STRUCTURE AND PROCESS OF PERIODIC SAFETY UPDATE REPORTING SYSTEM MEDICINES IN KENYA KIOGORA MWITI GATIMBU REG NO.U51/64042/2013 M.PHARM-EPIVIGIL 24 TH.

Objectives Why we need DHCPL Situations that call for a DHCPL Definitions DHCPL itself–content, presentation, process Target audience Current and future.

Benefits for using a standardised risk management framework to risk assess Infection Prevention and Control Sue Greig Senior Project Officer National.

Your global support in Europe Over 20 years of experience ELM Pharmaceutica.

ELM Farmacéutica. MEDICINAL PRODUCTS From development to marketing Development Dossier in European form Marketing authorization in UE Marketing Meetings.

Healing Hands Clinical Research Services is a clinical Research Service Provider which has broad spectrum of.

Healing Hands Clinical Research Services is a Site Management organization with broad spectrum of activities.

GIQAR Annual Congress 25 – 26 th May Pv QA: Quality Assurance for Pharmacovigilance Allison Jack Manager, R&D Oversight – GCP/PV, Pfizer Ltd BARQA.

 Pharmacovigilance – Patient’s standpoint Steve Arlington May 2007.

Requirements of EU pharmacovigilance legislation for distributors Julia Sipos Quality Management Director Pharmacovigilance coordinator Version 03.

Safety data collected during clinical trials is incorporated into the product’s approved label. Regulatory reviewers monitor products’ safety profiles.

Regulatory Update Ellen Leinfuss SVP, Life Sciences.

Eureka Pre-Clinical Investigation Animal toxicology Animal pharmacokinetics/ pharmacodynamics Clinical Investigation Phase I Safety and pharmacology Phase.

Target Institute of Medical Education & Research (TIMER) Provides Clinical Research services to Pharmaceutical, Biotechnology product companies right.

Pharmacovigilance obligations of the Pharmaceutical companies in India

Pharmacovigilance Programme of India

ACCREDITED CONSULTANTS PVT LTD. (ACPL) WELCOMES YOU.

H. Lundbeck A/S21-Sep-151 Pharmacovigilance during clinical development SAE reporting, ASUR and PSUR IFF Seminar, 21. February 2007.

PHARMACOVIGILANCE AND CLINICAL TRIALS DIVISION 20 August 2015 Victoria Falls Protecting Your Right to Quality Medicines and Medical Devices.

Topic 6 Understanding and managing clinical risk.

K NOWLEDGE S ERVICE E XPERIENCE Integrated Clinical Solutions.

Sten Olsson WHO Programme Expert Uppsala Monitoring Centre Sweden

Key Compliance Risks in Clinical Trials Kathleen Meriwether Principal, ERNST & YOUNG, LLP Fraud Investigation & Dispute Services.

Pharmacy and Poisons Board Pharmacy and Poisons Board, Kenya Role of Regulation in Optimizing Medicine use KNH/UON Pharmacy Symposium Optimizing Medicine.

Mr.Medicine (A unit of MR Medicine India Pvt. Ltd.) Get Well Soon.

Regulators’ response to consultation on EU legislative proposals for pharmacovigilance : common themes 2 nd International Pharmaceutical Regulatory and.

Registering the care sector – next steps Dr Linda Hutchinson Director, Care Quality Commission National Care Association Conference, 21 October 2010.

Drug Safety Regulations and Guidelines: A Practical Interpretation

FDA Regulation Economically Harmful & Morally Indefensible.

Dr Mary Couper Quality Assurance and Safety of Medicines WHO

Why have RMPs been required?

Minimum requirements for Pharmacovigilance in countries.

Postmarketing Pharmacovigilance Practice at FDA Lanh Green, Pharm.D., M.P.H. Office of Surveillance and Epidemiology June 21, 2006.

European Patients’ Academy on Therapeutic Innovation Introduction to pharmacovigilance Monitoring the safety of medicines.

PHARMACOVIGILANCE PLAN FOR TANZANIA PREPARED BY EMMA & MARY 10 TH SEPTEMBER 2004.

Comments on FDA Concept Paper Sidney N. Kahn, MD, PhD President Pharmacovigilance & Risk Management, Inc. Risk Assessment of Observational.

FINDING A PRACTICUM Lauri Rich – Career Services Ryan Gallagan- Career Services

Documentation Requirements for Hospital Accreditation -By Global Manager Group.

Prepared by: Imon Rahman Lecturer Department of Pharmacy BRAC University.

1 From Regulatory Intelligence to Compliance Debbie Henderson Head, Global Regulatory Policy EU Ring May 13, 2014.

1 Division of Pharmacoepidemiology and Pharmacovigilance AEMPS Dolores Montero Corominas 20 November Management of the Adverse drug reaction (ADR),

1 Pharmacovigilance & the New National Adverse Drug Reaction (ADR) Reporting System Michael Bonett, Quality Assessor Post-Licensing Directorate Medicines.

Proposal and Company Information Document CONTENT About Indagatio Research Our Research Offerings Why Indagatio Research Our Work Process Project Snapshot.

Internal Medicine Specialists & Mailing List Thinking of marketing Lists? Think of Global B2B Contacts! Reach global business prospects with.

1 PHARMACOVIGILANCE & THE NATIONAL ADVERSE DRUG REACTION (ADR) REPORTING SYSTEM Sarah Spiteri Post-Licensing Directorate Medicines Authority.

Adverse Event (AE) Coding Data mining and cleaning Medical literature screening and report writing Cleaning juggled Drug- AE data and converting to machine.

© 2016 Global Market Insights, Inc. USA. All Rights Reserved Fuel Cell Market size worth $25.5bn by 2024 Pharmacovigilance Market Size,

Social Pharmacy and Pharmacovigilance

Efficacy and Safety of Medicines

Risk Communication in Medicines

Agkem Impex Pvt. Ltd.

EudraVigilance.

11 viii. Develop capacity for signal detection and causality assessment Multi-partner training package on active TB drug safety monitoring and management.

FDA Guidance for Industry and FDA Staff Summary of Public Notification of Emerging Postmarket Medical Device Signals (“Emerging Signals”) Effective: December.

CDRH 2010 Strategic Priorities

HOW TO FULFILL STATUTORY REQUIREMENTS ON PRODUCT RELATED HEALTH INFORMATION Samina Qureshi, M.D. PSI INTERNATIONAL Inc.

Information Transfer – ROP Compliance

Scientific competence Communication and transparency

First meeting of the CIOMS Working Group XI: Patient involvement in the development and safe use of medicines April 2018, Geneva Mary O’Hare,

Updates to the PhRMA Code on Interactions with Healthcare Professionals National Pharma Audioconference August 5, 2008.

REAL WORLD CASE STUDY.

All Professionals are involved in

PHARMACOVIGILANCE SYSTEM

Presentation transcript:

ACCREDITED CONSULTANTS PVT LTD. (ACPL) WELCOMES YOU Your PHARMACOVIGILANCE PARTNER

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. 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. ACCREDITED CONSULTANTS PVT LTD. (ACPL)

ACPL is the leading Pharmacovigilance service provider in India. We provide a wide range of pharmacovigilance consultative services to various pharmaceutical companies across the world. ACPL is the leading Pharmacovigilance service provider in India. We provide a wide range of pharmacovigilance consultative services to various pharmaceutical companies across the world. ACCREDITED CONSULTANTS PVT LTD. (ACPL)

Our Aim & Goal Adhere the regulatory standards and maintain the compliance which helps to Our Aim & Goal Adhere the regulatory standards and maintain the compliance which helps to ACCREDITED CONSULTANTS PVT LTD. (ACPL)  Improve Patient Care  Improve Public Health  Risk Benefit Assessment of medicine  effective communication to health professionals & the public

Consulting Services that meet your needs Consulting Services that meet your needs ACCREDITED CONSULTANTS PVT LTD. (ACPL)

ACPL provides a wide range of pharmacovigilance services ACCREDITED CONSULTANTS PVT LTD. (ACPL) 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

Aggregate/Periodic Report Writing & Submission ACCREDITED CONSULTANTS PVT LTD. (ACPL)  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.

Routine safety surveillance, signal detection & Management Routine safety surveillance, signal detection & Management ACCREDITED CONSULTANTS PVT LTD. (ACPL)  Collection of ICSRs from database  Data cleaning & duplicate detection  Signal interpretation (by quantitative or statistical methods)  Assessment for signals  Recommendation for action (including label update analysis and physician review)

Risk Management Plans (RMPs) ACCREDITED CONSULTANTS PVT LTD. (ACPL) Risk-benefit management and analysis: ACPL provides strategic advice and analysis to develop updates risk management plans.

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 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 ACCREDITED CONSULTANTS PVT LTD. (ACPL)

ACCREDITED CONSULTANTS PVT LTD. (ACPL) ACCREDITED CONSULTANTS PVT. LTD. ( (Website: acplgroupindia.co.in) (Contact: , , , Fax: ) D-29, 1 ST FLOOR, ACHARYA NIKETAN, MAYUR VIHAR PHASE-I, NEW DELHI