Pharmacovigilance

Educe offers a cost-effective adverse event management system. We manage the legacy safety data and company's future needs for processing individual case safety reports.

Educe Solutions offers you complete service for case management which comprises of collection of safety relevant data by literature search, assessment of suspected ADRs from the literature, competent authorities and the spontaneous reporting system as well as electronic reporting.

Adverse event management is an end to end system and includes case triage, data entry, quality control, MedDRA coding, medical review, reportability assessment, regulatory reporting and follow-up. Our experienced pharmacovigilance physicians are involved in reviewing MedDRA coding and quality check of all cases.

The core processes and services include:

  • Adverse Events and Serious Adverse Events logging, data entry
  • Adverse Events and Serious Adverse Events case processing
  • Serious Adverse Events narrative writing
  • Safety medical assessments by the physician
  • Expedited reporting according to regulatory requirements
  • E2B electronic reporting format generation
  • Literature search and reviews
  • Management of follow-up cases
  • Compliance monitoring and QC

Aggregate Reports Management

Benefit Risk Evaluation Reports (PBRERs) and Periodic Safety Update Reports (PSURs) are a valuable source of pharmacovigilance data for the competent authorities. The MAHs should review the safety profile of their products and ensure that the Summary of Product Characteristics and Package Leaflet are up to date. The competent authorities plays great importance on compliance with periodic reporting.

At Educe we have years of experience in planning, write-ups and submission of safety reports.

  • PBRER/PSUR strategy and procedures
  • Preparation of Periodic Safety Update Report
  • Preparation of Addendums and Summary Bridging Report
  • Pharmacovigilance Physician review
  • Management of PSUR reporting requirements
  • Training of Client personnel in PBRER/PSUR handling, management and reporting

Signal Detection and Analysis

Signal detection is a key component of pharmacovigilance and the whole process of risk/benefit evaluation depends on the effectiveness of signal management system.

Educe's proactive signal management system.

Educe provides companies with:

  • Signal Detection and analysis for the products
  • Review of current signal management practices
  • Assess Individual case and aggregate reports for signal evaluation
  • Medical monitoring of safety signals on a monthly or quarterly basis
  • Data mining signal detection tools
  • Drug Safety Algorithms (DSAs)

Safety Risk Management

Safety Risk Management and assessment of risk-benefit balance is crucial both in clinical development and post marketing safety of medicines. Risk minimization involves minimizing a product's risk while preserving its benefits.

USFDA requires a Risk Evaluation and Mitigation Strategy (REMS) from manufacturers to ensure that the benefits of a drug or biological product outweigh its risks.

Educe provides companies with the following Risk Management and support services.

The core processes and services include:

  • Risk Management consulting
  • Preparation of communication plan
  • Risk Management plan
  • Routine risk minimization activities
  • Risk Evaluation and Mitigation Strategies (US-REMS)
  • European Union Risk Management Programs (EU-RMP)
  • Post-marketing requirement studies
  • Observational studies
  • Epidemiology studies
  • Safety-surveillance studies

Medical/Scientific Literature Search

Regular monitoring of worldwide medical and scientific literature forms an integral part of the ongoing safety surveillance of products.

At Educe, we perform:

  • Weekly/Ongoing Literature search
  • Identification and management of safety related data
  • API/Product Specific Literature Search
  • PSUR Literature search and analysis
  • Identification of ICSRs in reports

Quality and Compliance

Quality systems should be in place for all the pharmacovigilance activities to ensure effective monitoring of compliance and the accurate and proper documentation of all the measures taken.

Educe helps companies to establish and follow a quality system that is adequate and effective for performing pharmacovigilance activities. It covers the responsibilities, procedures, processes and resources and includes appropriate resource management, compliance management and record management.
Performance indicators are used to continuously monitor the performance of pharmacovigilance activities in line with the implemented quality system

At Educe our compliance activities include:

  • Regulatory audits and inspections
  • Record management and Data retention
  • Pharmacovigilance Operations compliance
  • Standard Operating Procedures compliance
  • Training and standards compliance

Regulatory Services

Each product is unique and the well planned regulatory strategies are important for their approvals. Educe provides expert clinical and regulatory support for all phases of global drug development.

We support clinical and regulatory activities in the USA, European Union, as well as the emerging markets of Asia Pacific, Latin America, and Central and Eastern Europe. Educe works with the companies to provide a seamless progression for drug registration.

Our services include:

Strategic planning and Consultancy

  • Development and execution of regulatory strategies
  • Lifecycle development planning
  • Regulatory gap analysis & due diligence
  • Protocol development and production
  • Scientific advice, expert oversight and review of data
  • Document authoring and review services
  • Advice and strategy for European and FDA submission procedures
  • Interpretation of guidelines and opinion on regulatory requirements
  • Agency management & liaison
  • Follow-up strategies and action

Regulatory Submissions and Support

  • Applications for new drugs and line extensions (centralised, decentralized, mutual Recognition and national)
  • CTD preparation of modules, overviews and summaries
  • Licence renewals and Variations Type I and Type II
  • Orphan drug applications
  • Summary of Product Characteristics, Patient Information Leaflet and labeling
  • Prescribing information preparation and review
  • Clinical trial applications
  • Paediatric Investigational Plans
  • Promotional material review and approval

Post-approval & Maintenance

  • Variations and supplements
  • Maintenance and regulatory life cycle management
  • Full Pharmacovigilance and drug safety services

Global Labeling Management

ENCOUNTERS

Is it challenging in ---

  • Harmonization of local labels across the geographical regions
  • Implementation of the revised product information
  • Translation activities, Brand comparisons
  • Revision of CCDS/SmPC/RSI/CCSI/Local Label

BUSINESS ESSENTIALS

Are you Looking for ---

  • Single strategic partner to ensure that the local product labels (SmPC/PL/Label) are aligned to the latest CCDS for all its products across multiple local markets in Europe
  • The labels also to be localized for local language and regulatory compliance
  • Work streams: SmPC/PL/Label updates; Proof reading and Repeat label

OUR METHOD & RESULTS

We Will---

  • Establish offshore hubs, leveraging clinical expertise, geographical diversity and scale to manage this extremely complex process
  • Deploy highly trained, scientific FTEs in Asia hubs of India for SmPC/PL/Label updates
  • Deploy FTEs for artwork management and proofing

Global Regulatory Labeling Management Services

Regulatory Intelligence and Strategy

  • Submission management
  • Regulatory dossier compilation, publishing and dispatch
  • Market authorization
  • Post-approval lifecycle management
  • Report compilation and publishing

Label Development

Development of target product profiles

  • Development of target Labeling and Artworks
  • Development of Investigational Brochure
  • Design and writing of Labeling content & Mock-ups
  • Management of non-compliant proposed Labeling content

Product Information

Creation of Product Information (SmPC/PL/Label)

  • Comparative analysis of local label content - Gap Analysis
  • Labeling project management systems to manage requests, decision documentation, implementation tracking, and integration of product knowledge bases
  • Product Naming & National submissions