Regulatory Services in Mexico
Regulatory Services in USA
Regulatory Services in Canada
Regulatory Services in Malaysia
Regulatory Services in Singapore
Regulatory Services in India
Regulatory Services in China
Regulatory Services in Indonesia
Regulatory Services in Philippines
Regulatory Services in Vietnam
Regulatory Services in Morocco
Regulatory Services in UAE
Regulatory Services in Kenya
Regulatory Services in Turkey
Regulatory Services in Saudi Arabia
Regulatory Services in Jordan
Regulatory Services in Egypt
Regulatory Services in Colombia
Regulatory Services in Japan
Regulatory Services in South Korea
Regulatory Services in Kazakhstan
Regulatory Services in Italy
Regulatory Services in Latvia
Regulatory Services in UK
Regulatory Services in Belgium
Regulatory Services in Spain
Regulatory Services in Australia
Regulatory Services in South AfricaPharmacovigilance Services in Canada
In Canada, it is mandatory to have a pharmacovigilance system to assure continuous monitoring of medicinal products and medical devices for their safe use. The Canada Vigilance Program is Health Canada’s pharmacovigilance program that is accountable for collecting and assessing the adverse drug reaction reports of health products. Anyone including health care professionals, patients/consumers, manufacturers, and distributors can submit the adverse drug reaction (ADR) reports directly to Health Canada or to Marketing Authorization holders. There are seven regional offices of Canada Vigilance which act as regional points of contact for the health professionals and support The Canada Vigilance Program to collect reports from these regions which are further forwarded to the Canada Vigilance National Office for further analysis. In addition to this Canada maintains Canada Vigilance Online Database for all the suspected adverse drug reaction reports.
As a leading global contender, DDReg understands the significance of patient safety right from clinical trials to post-marketing surveillance of medicinal products. As part of our safety services portfolio for Canada, we provide end to end pharmacovigilance services that include adverse drug reaction reporting, signal detection & management, aggregate report writing, development of customized pharmacovigilance plans/risk management plans in accordance with the local requirements and good pharmacovigilance practices.
DDReg pharmacovigilance Services portfolio include:
ICSR Processing and Submission
- Triage of initial and follow-up ICSRs, SUSARs,
- CCase Processing through E2B(R3) compliant databases and other relevant databases integrated with Drug dictionary (WHO DD) and MedDRA
- Quality Check, Medical reviews
- Submission of cases as per agency timelines
- Maintaining ICSR monitoring & tracking sheets
- Reconciliation process with customers
Risk Management Plan
- Drafting, reviewing, and maintaining RMPs and REMS while providing support through submission methods
- Preparing customized procedures to classify safety risks and deliver tailored risk management strategies
- Assessment of potential risks and missing information and prepare reports that recommend risk management methods
- Implementation of supplementary measures, including Post-Authorization Safety Studies (PASS), such as developing academic materials, observational examinations, and targeted follow-up questionnaires
- Effectively convey risks through labelling means such as Summary of Product Characteristics (SmPC) and patient information leaflet (PIL) (PIL)
Aggregate Reports
- Periodic Benefit-Risk Evaluation Report (PBRERs)
- Periodic Safety Update Report (PSURs)
- Periodic Adverse Drug Experience Reports (PADERs)
- Development Safety Update Reports (DSURs)
- Annual Safety Reports (ASRs)
Signal Management
- Identification new safety signals and/or changes in risks concerning a pharmaceutical product from ICSR database, literature, aggregate reports as well as regulatory agency website monitoring.
- Utilizes a variety of in-house tools and databases for signal detection and tracking signal management processes
- Reviews safety signals for ICSRs, aggregate reports and recommendations by Pharmacovigilance Risk Assessment Committee (PRAC)
- Performs label update analysis
- Provide recommendations from signal assessments which include risk minimization approaches
- Preparation of Signal Management Tracker, Annual Signal Reports.
QPPV Services
- Review of PSMF, SDEA agreements, agreements with commercial partners, PV SOPs etcs
- Review & sign off of Aggregate reports, Signal Reports and RMPs
- Retainer services for QPPV and Deputy
- Monthly reconciliation
- Medical review of Signal detection ; Signal Surveillance Meetings (Quarterly)
- Monthly Communication report/provision of compliance metrics
- PV Quality Management System Oversight
PV Audit & Compliance
- Review compliance audit to applicable PV guidelines, regulations, Safety Data Exchange Agreements (SDEAs), SOPs (standard operating procedures) and work instructions
- Optimize well-constructed audit plans as well as mock audits to prepare customer organizations for PV inspections conducted by respective competent authority.
- Conduct regular gap assessments of PV staff at site location
- Provide organizational training on safety audits and inspections
Country Specific Services
- Regulatory Strategies / Expert Views
- Regulatory Due Diligence
- Gap Analysis and Remediation
- New Product Authorizations
- Post Approval Life Cycle Management
- CMC Advisory
- Regulatory Services in India
- Regulatory Services in Mexico
- Regulatory Services in USA
- Regulatory Services in Canada
- Regulatory Services in Malaysia
- Regulatory Services in Singapore
- Regulatory Services in China
- Regulatory Services in Indonesia
- Regulatory Services in Philippines
- Regulatory Services in Vietnam
- Regulatory Services in Morocco
- Regulatory Services in UAE
- Regulatory Services in Kenya
- Regulatory Services in Turkey
- Regulatory Services in Saudi Arabia
- Regulatory Services in Jordan
- Regulatory Services in Egypt
- Regulatory Services in Colombia
- Regulatory Services in Japan
- Regulatory Services in South Korea
- Regulatory Services in South Africa
- Regulatory Services in Kazakhstan
- Regulatory Services in Italy
- Regulatory Services in Latvia
- Regulatory Services in UK
- Regulatory Services in Belgium
- Regulatory Services in Spain
- Regulatory Services in Australia
- Aggregate Reports
- Literature Monitoring
- Risk Management
- ICSR Processing & Submission
- Signal Management
- Audit and Compliance
- QPPV Services
- Pharmacovigilance Services in Mexico
- Pharmacovigilance Services in USA
- Pharmacovigilance Services in Canada
- Pharmacovigilance Services in Malaysia
- Pharmacovigilance services in Singapore
- Pharmacovigilance Services in India
- Pharmacovigilance Services in China
- Pharmacovigilance Services in Indonesia
- Pharmacovigilance Services in Philippines
- Pharmacovigilance Services in Vietnam
- Pharmacovigilance Services in Morocco
- Pharmacovigilance Services in Kenya
- Pharmacovigilance Services in Turkey
- Pharmacovigilance services in Saudi Arabia
- Pharmacovigilance Services in Jordan
- Pharmacovigilance Services in Egypt
- Pharmacovigilance Services in Japan
- Pharmacovigilance services in South Korea
- Pharmacovigilance Services in South Africa
- Pharmacovigilance Services in Kazakhstan
- Pharmacovigilance Services in Australia
- Pharmacovigilance services in UAE
- Pharmacovigilance Services in Colombia
- Pharmacovigilance services in Italy
- Pharmacovigilance services in Latvia
- Pharmacovigilance services in Belgium
- Pharmacovigilance services in Spain
- Pharmacovigilance services in UK
- DDReg's Publishing services
- DDReg's Medical Writing services
