Skip to content
Browse all Ennov pages.
Posts
- Meet us at DIA – Euro Meeting 2015
- Ennov at ASQ 2015 – World Conference on Quality & Improvement
- Ennov at DIA eCTD+ RIM Conference 2015
- PV-Works is Ennov’s new Pharmacovigilance Solution.
- Ennov at 2015 PDA Annual Meeting- Parenteral Drug Association
- Ennov Pharmacovigilance|User Meeting
- Visit us at ASQ 2015 on May 4-6 | Booth 334
- Join us at DIA eRegulatory and Intelligence | Booth 100
- Join us at DIA 2015 51st Annual Meeting| Booth 1145
- Join us at RAPS Regulatory Convergence 2015 | Booth 312
- Discover our exclusive new cloud-based service: eCTD247
- Ennov launches its new RIM software solution on the DIA 2016 Conference: join us and learn how to best manage your regulatory documents and processes
- Join Ennov at RAPS Regulatory Convergence 2016 – Booth 401
- Webinar: Streamline Quality Management with a Modern QMS
- Ennov recognized by Gartner in the Hype Cycles for Life Sciences
- Ennov recognized by Gartner as a RIM and IDMP vendor
- Webinar: Quality Management Solution for Low Cost SOP, Deviation, CAPA Best Practices
- Nov. 3rd Webinar: Discover eCTD 247 – cloud-based Regulatory submission service
- Nov. 16th Webinar: Ennov’s PV247 cloud pharmacovigilance system
- Reduce Costs with Integrated Quality Management for Pharma: RQA2016 Booth18
- Implement GMPs with an Integrated QMS: GAMP 5 Quality conference, Mannheim
- Dec. 15th Webinar: Quality Management Solution for Low Cost SOP, Deviation, CAPA Best Practices
- Submit your PSUR in eCTD format with eCTD247
- DIA Conference Washington DC – 23rd to 25th January
- DIA Forum Bethesda, MD- February 6th to the 8th
- DIA Euromeeting Glasgow, Scotland- March 29th to the 31st
- ISPE 2017 Europe Annual Conference in Barcelona, Spain- April 3rd to the 5th
- ASQ 2017 World Conference in Charlotte, US- May 1st to the 3rd
- DIA 2017 Annual Meeting in Chicago, US- June 18th to the 22nd
- RAPS 2017 Regulatory Convergence National Harbor, MD USA
- SCDM 2017 Annual Conference in Orlando, FL USA- September 24th to the 27th
- Fleming. 4th Annual Pharmacovigilance and Risk Management Strategies Forum, US
- Ennov Clinical EDC Version 8 Released and CDISC Certified
- Sept. 13th/27th Webinars: Ennov’s cloud Regulatory Submission Service – Discover eCTD247
- The New Ennov 8 is Now Available!
- TOPRA Regulatory Affairs Symposium, London, 2nd-4th Oct.
- Webinar: Introduction to Ennov Clinical (Nov 14, 11AM EST)
- Ennov’s Blog is Live
- Ennov to exhibit at Partnerships in Clinical Trials – Europe
- Ennov Attends the SCDM 2017 Conference in Orlando, Florida
- Top 5 eTMF Features | etmf systems
- Our Journey with Scrum
- Ennov Announces AtEvent Acquisition
- Ennov to Exhibit at the SCOPE Summit February 13-14, 2018 in Orlando, Florida
- EudraVigilance Update, GVP Module IX, and the Impact on Signal Detection
- Ennov to Exhibit at the DIA RSIDM Forum February 5-7, 2018 in Bethesda, MD
- Ennov Annual USA User Meeting – New Orleans – April 9-12th 2018
- Ennov USA User Group Announcement
- Ennov to Exhibit at the 2018 DIA Global Annual Meeting, June 25-27 in Boston, MA
- Ennov to Exhibit at SCDM Annual Conference September 23-26,2018, Seattle-Bellevue
- Ennov to Exhibit at 2018 RAPS Regulatory Convergence, October 1-4 in Vancouver, BC
- Ennov and PQLOGIX Partner to Bring Quality Management Software to the Chinese Market
- Ennov Named a Representative Vendor by Gartner in 2018 Market Guide for Quality Management System Software
- Ennov V8.3 announcement
- Ennov Exhibits at PCT-Europe 2018 Conference in Barcelona
- Ennov will be exhibiting at the DIA Pharmacovigilance and Risk Management Strategies Conference
- Ennov to Exhibit at the 10th Annual SCOPE Summit for Clinical Ops Executives
- Ennov to Exhibit at the 2019 DIA RSIDM Forum
- Boehringer Ingelheim selects the Ennov platform for Regulatory Information Management
- Ennov PV – An Auto-Testing Revolution
- Ennov will be exhibiting at the 2019 Global Pharmaceutical Regulatory Affairs Summit
- Ennov User Meeting 2019
- Ennov is Recognized in Gens & Associates 2018 World Class RIM Study
- Top 25 Pharmaceutical Company Selects Ennov for Global Regulatory Information Management
- Ennov to Exhibit at the 2019 DIA Global Annual Meeting, June 23-27 in San Diego, CA
- Ennov and Genpact Announce New Partnership
- Ennov Named a Representative Vendor by Gartner in 2019 Market Guide for Life Science E-Clinical Platforms
- Risk-Based Monitoring Improved
- Ennov to Exhibit at the 2019 RAPS Regulatory Convergence being held 21-24 September 2019 at the Philadelphia Convention
- Answering Complex Questions with RIM: Helping Sponsors Manage Divestitures
- 6 Considerations for Selecting an EDC Solution
- Ennov Recognized by Garner in Multiple 2019 Research Reports
- RIM Webinar – Understand the Basics of RIM in 30 Minutes
- Ennov to Sponsor 9th TMF Summit and CROWN Congress January 21-23, 2020 in Orlando, FL
- FDA Eliminates the need for Paper Device Submissions
- Optimize Your eTMF Strategy
- Ennov to Exhibit at the 2020 DIA Regulatory Submissions, Information and Document Management (RSIDM) Forum
- Ennov and fme Life Sciences Announce New Partnership
- Ennov to present the latest version of its game-changing RIM at the 2020 Global Pharmaceutical Regulatory Affairs Summit, Berlin, April 21-23
- Hosting GCP Inspections: Six interesting takeaways from the MHRA’s Blog Post
- FDA Guidance on Post-marketing Adverse Event Reporting During a Pandemic
- Webinar: Mastering The Challenges of RIM Data Migration
- Ennov Announces the Release of Version 8.6 with Full XEVMPD Support
- Synairgen Selects Ennov PV to Support COVID-19 Clinical Trial
- Ennov Recognized by Gartner in 2020 Market Guide for Quality Management System Software
- Ennov is Recognized in Gens & Associates 2020 World Class RIM Study
- Case Study: Laboratoire Aguettant
- Case Study: Almedis
- Case Study: Pure Drug Safety
- Case Study: Septodont
- Case Study: Vetoquinol
- Optimize Your TMF Strategy
- Managing Clinical CAPAs
- White Paper: Unified CTMS and eTMF
- eDMS and Office 365 Integration
- eDMS and IDMP
- Ennov and 21 CFR Part 11
- Unified RIM and xEVMPD
- Product Demo: Unified CTMS and eTMF
- Migrating Legacy Documents to Ennov
- Unified QMS and RIM
- FDA Issues Final Guidance on Civil Money Penalties Relating to ClinicalTrials.gov
- Preparing for IDMP: Insights from the Gens & Associates survey
- Clinical CAPAs: Are Your Trials in a State of Control?
- Smart Signal Management in Pharmacovigilance
- Ennov Announces the Expansion of the Regulatory Team
- Pharmacosmos Adopts Ennov to Support Quality/GxP Operations
- Unified PV and RIM
- Integrating Documentum and Ennov RIM
- Ennov Launches the Ennov Insider
- Ennov CTMS Dashboards
- RIM Webinar: Accelerate Time to Value by Leveraging Predefined Regulatory Processes
- FDA Removes Two-Way Communication from eCTD 4.0
- Gartner: Hype Cycle for Life Science Research and Development, 2020
- MHRA TMF Inspection Finding Checklist
- MHRA Trial Master File (TMF) GCP Inspection Findings: Trends and Takeaways
- FDA News: FDA Updates Various eCTD Documents
- Gartner market Guide for Life Science Regulatory Information Management Solutions
- Regulatory Webinar: Ennov Dashboards in Action: Visualize Your Regulatory Risk and Status
- Pharmacovigilance Signal Detection and Data Analysis
- Brexit Lingers on in the RIM World
- Accelerate Time to Value by Leveraging Predefined Regulatory Processes
- Visualize Your Regulatory Risk and Status with Ennov Analytics
- Visualize Your Clinical Risk and Status with Ennov Analytics
- Gartner | Strategic Life Science Regulatory Information Management: From Fragmented to Holistic
- Webinar : Manage larger and more numerous clinical studies with our dedicated software platform
- Archiving a CRO-Generated eTMF: Considerations for Sponsors
- Ennov Recognized by Gartner in the 2021 Hype Cycle for Life Sciences R&D
- Ennov to Sponsor the Clinical Quality Oversight Forum
- Ennov RIM platform implemented at Boehringer Ingelheim
- Case Study: Bachem
- FDA eCTD-Related News
- Ennov to Sponsor 10th TMF Summit
- Case Study: Pharma IT
- White Paper: Clinical Analytics: The Journey from Problem Identification to Solution
- Ennov Opens New Office in Vietnam
- Interview with Regulatory Expert Steve Clark: Asphalion’s RegTalks RIM Series, Part I
- Maintaining Compliance: Adapting to Changing Requirements
- Interview with Regulatory Expert Steve Clark: Asphalion’s RegTalks RIM Series, Part II
- Interview with Regulatory Expert Steve Clark: Asphalion’s RegTalks RIM Series, Part III
- Summary of Updates: Version 2.1 of the EMA IDMP Implementation Guide
- Completeness, Quality and Timeliness: A Deep Dive
- Ennov to Exhibit at the 6th European Conference on Clinical Research
- Case Study: IRE
- The Journey to Risk-Based Clinical Analytics
- Ennov to Exhibit at the 2022 DIA RSIDM Forum
- Ennov to Sponsor the AFCROs Clinical Research Day
- 4 Ways to Reduce Regulatory Risk Using RIM
- Ennov Opens New Office in the US
- Ennov’s Humanitarian Response to the Crisis in Ukraine
- Ennov to Sponsor the 2022 Global Pharmaceutical Regulatory Affairs Summit
- Ennov Announces the Release of Version 9.3
- Ennov Acquires MACRO from Elsevier to Reinforce its Leadership Position in the EDC Field
- Ennov to Sponsor TMF Summit
- 5 Myths About eTMF
- Dendreon Selects Ennov’s Unified Regulatory Suite
- IDMP Considerations in 2022: Interoperable Structured Data Reporting
- Signal Detection
- Adverse Drug Reaction (ADR)
- Abbreviated New Drug Application (ANDA)
- Abridged Application
- Active Pharmaceutical Ingredient (API)
- Active Substance
- Drug Substance (DS)
- Active Substance Master File (ASMF)
- Adjuvant
- Amendment
- Analysis Data Model (AdAM)
- Analysis Datasets
- Anatomical Therapeutic Chemical Classification System (ATC)
- Annotated Case Report Form
- Annotated ECG waveform data
- Annual Report
- Applicant
- Application Number
- Approval Letter
- ASEAN Common Technical Document (ACTD)
- Biologic Product
- Biologics License Applications (BLA)
- Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)
- CE Mark (CE)
- Center for Biologics Evaluation and Research (CBER)
- Center for Devices and Radiological Health (CDRH)
- Center for Drug Evaluation and Research (CDER)
- Centralised Procedure (CP)
- Centrally-Authorised Procedure (CAP)
- Certificate of Suitability (CEP)
- Checksum
- Chemical Abstracts Service Registry Number (CAS Number)
- Chemistry, Manufacturing and Controls (CMC)
- Clinical Data Interchange Standards Consortium (CDISC)
- Clinical Trial Applications (CTA)
- Manufacturing Supplement
- CMC Supplement
- Code of Federal Regulations (CFR)
- Commitment
- Committee for Medicinal Products for Human Use (CHMP)
- Common Technical Document (CTD)
- Competent Authority
- Complete Response Letter
- Concerned Member State (CMS)
- Controlled Vocabulary
- Core Data Sheet (CDASH)
- DailyMed
- Data Definition File
- Data Listings
- Data Tabulation Datasets
- Decentralised Procedure (DCP)
- Define.xml
- Medical Device
- Device
- Digital Application Dataset Integration (DADI)
- Digital Signature
- Document Type Definition (DTD)
- Dosage Form
- Dosage Strength
- Drug Master File (DMF)
- Drug Product (DP)
- eCopy
- eCTD Backbone
- eCTD Validation Criteria
- Efficacy Supplement
- Electronic Application Form (eAF)
- Electronic Signature
- Electronic Submissions Gateway (ESG)
- Envelope
- European Directorate for the Quality of Medicines (EDQM)
- European Economic Area (EEA)
- European Medicines Agency (EMA)
- Excipient
- eXtended EudraVigilance Medicinal Dictionary (XEVMPD)
- eXtended EudraVigilance Product Report Message (XEVPRM)
- Fast Healthcare Interoperability Resources (FHIR)
- FDA 1571
- FDA 1572
- FDA 2253
- FDA 356h
- File Tag
- Food and Drug Administration (FDA)
- Generic Drug
- Global Trade Item Number (GTIN)
- Grouped Submission
- Guidance
- Gulf Co-operation Council (GCC)
- Health Canada
- ICH E3
- Identification of Medicinal Products (IDMP)
- Indication
- Integrated Summary of Efficacy (ISE)
- Integrated Summary of Safety (ISS)
- Intermediate (or Intermediate Product)
- International Council for Harmonisation (ICH)
- International Nonproprietary Name (INN)
- International Organization for Standardization (ISO)
- Investigation New Drug Application (IND)
- Investigational Medicinal Product Dossier (IMPD)
- Investigator’s Brochure (IB)
- Label
- Labeling Supplement
- Labelling
- Leaf Element
- Leaf Title
- Lifecycle Operations
- Marketing Authorisation Application (MAA)
- Marketing Authorisation Holder (MAH)
- Medical Dictionary for Regulatory Activities (MedDRA)
- Medicines and Healthcare products Regulatory Agency (MHRA)
- Module 1
- Module 2
- Module 3
- Module 4
- Module 5
- Mutual Recognition Procedure (MRP)
- National Competent Authority (NCA)
- Nationally Authorised Product (NAP)
- New Drug Application (NDA)
- Node Extension
- Non eCTD Electronic Submission (NeeS)
- Novel Excipient
- Organisation Management Service (OMS)
- Packaged Medicinal Product Identifier (PCID)
- Patient Package Insert (PPI)
- Pharmaceuticals and Medical Devices Agency (PMDA)
- Pharmacopoeia
- Pharmacovigilance Risk Assessment Committee (PRAC)
- Plasma Master File (PMF)
- Predicate Rule
- President’s Emergency Plan for AIDS Relief (PEPFAR)
- Priority Review
- Qualified Person Responsible For Pharmacovigilance (QPPV)
- Quality Overall Summary (QOS)
- Rapporteur
- Reference Listed Drug
- Reference Member State (RMS)
- Regulated Product Submissions (RPS)
- Regulatory Activity
- Regulatory Affairs
- Regulatory Information Management System (RIM / RIMS)
- Regulatory Intelligence
- Related Sequence
- Rolling Submission
- Route of Administration
- Sequence
- Sequence Number
- Sponsor
- Standard for Exchange of Nonclinical Data (SEND)
- Statistical Analysis System (SAS)
- Structured Product Labeling (SPL)
- Study Data Tabulation Model (SDTM)
- Study Tagging File (STF)
- Subject Profiles
- Submission
- Substance, Product, Organization, Referentials (SPOR)
- Summary of Product Characteristics (SmPC)
- Supplement
- Systemized NOmenclature of Medicine – Clinical Terms (SNOMED-CT)
- Therapeutic Area
- Trade Name
- Unique Ingredient Identifier (UNII)
- Universally Unique IDentifier (UUID)
- Variation
- Veterinary Non eCTD Electronic Submission (vNeeS)
- WebTrader
- Worksharing
- eTMF for Risk Management and Regulatory Compliance | Ep. 1: Guidance Review
- eTMF for Risk Management and Regulatory Compliance | Ep. 2: TMF Completeness
- Ennov to Exhibit at the 2022 DIA Global Annual Meeting, June 19-23 in Chicago, IL
- eTMF for Risk Management and Regulatory Compliance | Ep. 3: TMF Timeliness
- Ennov Serves as Global Patient Call Center Platform
- eTMF for Risk Management and Regulatory Compliance | Ep. 4: TMF Quality
- eTMF for Risk Management and Regulatory Compliance | Ep. 5: TMF Inspections
- eTMF for Risk Management and Regulatory Compliance | Ep. 6: Sponsor Access
- Ennov and Medical Edge Announce New Partnership
- Leveraging RIM for DADI and IDMP | Ep 1: Best Practices for Data Modeling
- Leveraging RIM for DADI and IDMP | Ep 2: Enterprise-Level Data Architecture
- Leveraging RIM for DADI and IDMP | Ep 3: Examples of Divergence
- Sponsor Oversight and the Role of eTMF | Webinar
- TMF Completeness: From Chaos to Order
- Ennov to Exhibit at the 2022 RAPS Regulatory Convergence
- FDA News Roundup for Reg Affairs-Reg Ops
- Ennov to Exhibit at the 2022 World Drug Safety Congress Europe
- RIM Analytics: Dashboards with a Purpose
- Ennov to Exhibit at ICTMC 2022
- IDMP and RIM: Perfect Together?
- Adaptive Clinical Trial
- ADME Study
- Adverse Event (AE)
- Arm
- Audit Certificate
- Auditor
- Bioavailability
- Blinding / Masking
- Case Report Form
- Certified Copy
- Clinical Study
- Clinical Study Report
- Clinical Trial Authorization (CTA)
- Clinicaltrials.gov
- Combination Product
- Comparator
- Contract Research Organization (CRO)
- Control
- Controlled Study
- Corrective And Preventative Action (CAPA)
- Crossover Study
- Data Monitoring Committee (DMC)
- Dose
- Dose-Ranging Study
- Double-Blind Research Design
- Dropout
- Electronic Data Capture (EDC)
- Electronic Patient Reported Outcome (ePRO)
- Patient-Reported Outcome (PRO)
- Endpoint
- Enrollment
- Exclusion Criteria
- Good Clinical Practice (GCP)
- Health Authority (HA)
- Important Protocol Deviation
- Inclusion Criteria
- Independent Ethics Committee
- Informed Consent
- Informed consent form (ICF)
- Inspection
- Inspector
- Institutional Review Board (IRB)
- Interim Analysis
- Interventional Study (Clinical Trial)
- Investigational Drug
- Investigational New Drug Application (IND)
- Investigational Product (IP)
- Investigational Site
- Investigator
- Lost to Follow Up
- Monitoring
- Monitoring Visit
- Monitoring Visit Report
- Multicenter Trial
- NCT Number
- Observational Study
- Open Label Study
- Orphan Drug
- Patient Registry
- Pharmacokinetics
- Phase
- Phase 0 (aka Early Phase 1)
- Phase 1
- Phase 2
- Phase 3
- Phase 4
- Pivotal Clinical Trial
- Placebo
- Principal Investigator
- Protocol
- Protocol Amendment
- Protocol Deviation
- Query
- Randomization
- Randomized Allocation
- Real World Studies
- Recruitment
- SAS
- SAS Transport Files
- Screening
- Single-Blind Research Design
- Study Coordinator
- Subinvestigator
- Subject
- Subject Number
- TMF Reference Model
- Uncontrolled Study
- Health Canada News Roundup for Reg Affairs-Reg Ops
- 3 Steps to Signal Detection in Pharmacovigilance
- Ennov to Sponsor the EUTMF Summit
- Adverse Event of Special Interest (AESI)
- Aggregate reports
- Association
- Benefit
- Benefit-Risk Assessments
- Benefit-Risk Balance (Effectiveness/Risk)
- Case Reports
- Causality Assessment
- Company Core Safety Information (CCSI)
- Company Core Data Sheet (CCDS)
- Council for International Organizations of Medical Sciences (CIOMS)
- Clinical Development Program
- Critical Terms
- Causal Relationship
- Data Monitoring Committee
- Dechallenge
- Rechallenge
- Development core safety information (DCSI)
- Development pharmacovigilance and risk management plan
- Disproportionality Analysis
- Designated Medical Event (DME)
- Drug Abuse
- Efficacy
- EUDRAGENE
- EudraVigilance
- Expected Adverse Drug Reaction
- Expedited Reporting
- Frequency of ADRs
- Good Pharmacovigilance Practice
- Harm
- Hazard
- ICH
- Important Medical Event (IME)
- Incidence
- Unlabeled (or Labelled)
- Medication Error
- Minimum Criteria for Reporting
- Missing Information
- National Pharmacovigilance Centers or National Competent Authority (NCA)
- Near-Misses
- Number Needed to Harm (NNH)
- Odds and Odds Ratio
- Off-Label Use or Misuse
- Overdose
- Post-Authorization Safety Study (PASS)
- Pharmacoepidemiology
- Pharmacology
- Pharmacovigilance
- Pharmacovigilance Master File
- Pharmacovigilance System
- Postmarketing Surveillance
- Predisposing Factors
- Prescription Event Monitoring (PEM)
- Prevalence
- QPPV
- Rational Drug Use
- Reference Risk (or Baseline Risk)
- Risk
- Risk Management
- Risk Management Plan (RMP)
- Risk Minimization Activity
- Serious Adverse Event (SAE) or Serious Adverse Reaction (SAR)
- International Serious Adverse Events Consortium (SAEC)
- Safety
- Safety Concern
- Safety Specification
- Signal
- Signal Management Process
- Signal Validation
- Solicited Reports
- Spontaneous Reporting
- Type (A to F) of Adverse Drug Reaction
- Unexpected Adverse Drug Reaction
- United States Prescribing Information (USPI)
- Vigibase
- WHO
- WHOART (WHO Adverse Reactions Terminology)
- WHO DD (WHO Drug Dictionary)
- Side Effect
- Unexpected Adverse Reaction
- Suspected Unexpected Serious Adverse Reaction (SUSAR)
- Abuse
- Seriousness vs. Severity
- Temporal Relationship
- Identified Risk
- Potential Risk
- Important Risk
- Developmental International Birth Date (DIBD)
- Data Lock Point (DLP)
- Development Safety Update Report (DSUR)
- International Birth Date (IBD)
- Periodic Safety Update Report (PSUR) / Periodic Benefit-Risk Evaluation Report (PBRER)
- Regulatory Authority
- Risk Management System (RMS)
- Ennov Announces the Release of Version 9.4
- Managing Post-Approval CMC Changes with RIM & QMS
- Case Study: PV Animal Health
- How Mobile EDC is Transforming Clinical Trials in 2023
- Benefits of Implementing an End-to-end RIM Platform
- Ennov to Exhibit at the 2023 DIA RSIDM Forum
- Ennov to Sponsor TMF Summit
- Unlocking the Future of Healthcare: Insights from the 2023 Gartner Report on Digital Transformation
- Unlock The Full Potential of Product Development with EDMS
- Streamlining your eTMF: 10 Best Practices for Reducing Both Effort and Risk | Webinar
- Finding the Right Fit: Key Considerations for Selecting an Integrated Quality Management System
- Sponsor Oversight and the Role of eTMF
- Maximizing Value in Healthcare: How CIOs Can Drive Ongoing Strategic Cost Optimization
- Why SMBs should choose a right-sized RIM | Regulatory Webinar
- Ennov RIM
- Case Study: Maincare
- Integrated Software: Revolutionizing Customer Complaints and CAPA Management
- Case Study: Horiba
- Enhancing Technology Strategy for Efficient Clinical Development
- Ennov Drives 30% Growth in 2022, Confirms Market Relevance
- Absolute Risk
- Academia
- Acceptable Risk
- Active Surveillance System
- Additional Risk Minimisation Measure
- Adoption
- Ennov’s Secret to Consistent Quality
- Common Reasons for eCTD Rejection by the FDA and How to Prevent Them
- Going Paperless: Best Practices for Creating Certified Copies
- Navigating Certified Copies: A Global Guide to FDA, EMA, and Beyond
- AGREE Instrument
- Alert
- Analysis of covariance (ANCOVA)
- Baseline characteristics
- Bayesian
- Bayesian confidence propagation neural network (BCPNN)
- Binary Analysis
- Biomarker
- Bonferroni Correction
- Ennov Sponsors the 2023 RAPS Euro Convergence
- Ennov Training
- Ennov Process
- Ennov eTMF
- Best Practices: Master Data Management
- Boxed warning (“black box warning”)
- Burden of a risk minimisation activity
- Burden to patients
- Ennov EDC
- Ennov Doc for Regulatory
- Ennov CTMS
- Ennov Doc
- Ennov Dossier
- Why SMBs should choose a right-sized RIM
- Empower Your Quality Management Journey with Gartner Market Guide Insights
- PV Made Simple | Pharmacovigilance Webinar
- Ennov Acquires RIM Solution Provider Samarind
- Candidate gene study
- Caregiver
- Case report form (CRF)
- Causality assessment
- Censored/Censoring of Data
- PV-Analyzer
- PV-Works Human
- PV-Works Vet
- PV-Signal Manager
- Streamlining your eTMF: 10 Best Practices for Reducing Both Effort and Risk
- Ennov to Exhibit at the 2023 DIA Global Annual Meeting, June 25-29 in Boston, MA
- Ennov’s Agnostic Solution for IDMP, the EASI connector
- Bonnes Pratiques Qualité : qui doit s’imposer, le logiciel ou vos pratiques ?
- Mastering Master Device Data: MDM Benefits for Compliance, Safety, Agility
- PV Made Simple
- QMS, les limites de la pré-validation par l’éditeur
- Top 5 Trends in Life Sciences in 2023: Driving the Future of Innovation
- Ennov’s Agnostic Solution for IDMP, the EASI connector
- Empowering Emerging Pharma Organizations through DLSP Strategy
- Best Practices: Cross-Referencing in eCTD
- Ennov to Attend 2023 CDISC TMF Interchange
- Gartner Insights: IDMP & EMA Compliance
- Ennov to Exhibit at RAPS Convergence 2023
- The Future of Regulatory Affairs: Decoding the 2023 RAPS Convergence Agenda
- Can IDMP Transform Pharma?
- Navigating IDMP Compliance: The Time is Now
- Ennov to Sponsor Global Pharmaceutical Regulatory Affairs Summit
- Navigating The Regulatory Landscape: The Ultimate Guide to Your IDMP Journey
- Ennov to Exhibit at the World Drug Safety Congress Americas 2023
- Ennov Forms Strategic Partnership with ION Pharma to Elevate Quality Management in Life Sciences
- The RAP Up: Trends from 2023 RAPS Convergence
- IDMP: What’s Different This Time?
- Ennov to Sponsor 9th Annual European Drug Safety Pharma & Biotech Conference
- La GED Ennov est désormais accessible en mode offline
- Navigate PV Safety with Confidence, Gain Instant Insights, and Take Action!
- IDMP without Data Re-entry
- Regulatory Compliance in the Cosmetics Industry
- The New Wave of QMS [1/8]: Setting the Stage for Modern Quality Management
- Strategic Safety Data Management for Cosmetic Compliance
- The New Wave of QMS [2/8]: Comprehensive Integration
- The New Wave of QMS [3/8]: Scalability
- The Future of Medical Device Regulation: Insights from Ennov’s Expert Working Group
- Ennov’s Medical Device Working Group Unites Industry Leaders
- Case Study: Pharmacosmos
- The New Wave of QMS [4/8]: Data-Driven Decisions
- Streamlining Operations with Digital Cosmetovigilance
- Sustainability in Safety: The Cosmetovigilance Approach
- Holistic Beauty and Safety Compliance: Bridging the Gap
- Ennov to Sponsor the 2024 DIA RSIDM Forum
- The Trust Equation: Safety, Branding, and Consumer Loyalty
- The New Wave of QMS [5/8]: User-Centric Interface
- The New Wave of QMS [6/8]: Flexibility & Adaptability
- The New Wave of QMS [7/8]: Cybersecurity Measures
- Unified Quality and Regulatory Information Management
- The New Wave of QMS [8/8]: Reflections & Looking Ahead
- Ennov Boosts Portfolio with Acquisition of DocShifter: The Market-Leading Document Transformation Solution
- Ennov Announces Strategic Acquisition of Calyx’s ‘Enterprise Technology’ Division
- Dermatological Safety Assurance with Unified Platforms
- AI-Driven Cosmetovigilance Solution for the Global Leader in Luxury
- Why Unified Platforms are the Future of Cosmetovigilance
- Artificial Intelligence (AI)
- New MoCRA Adverse Event Reporting Requirements: Impact on the Cosmetic Industry
- AI and Its Impact on Life Sciences
- Accelerating Drug Development: Unpacking FDA’s Master Protocol Guidance
- AI in Quality Management with ION Pharma
- Ennov to Sponsor the Pronovea Pharma Summit 2024
- Ennov to Sponsor the 2024 CDISC + TMF Europe Interchange
- How to Future-Proof MedDevice/MedTech Compliance
- Compliance Without Compromise: Med Device Edition
- Ennov to Exhibit at the 2024 DIA Global Annual Meeting, June 16-20 in San Diego, CA
- Gartner Insights: Maximize Your QMS Success with Peer Guidance
- Future-Proofing Quality Management: A Guide for SMBs in Life Sciences
- Ennov Completes the Enterprise Technology Integration from Calyx
- Ennov RIM for Med Device
- Cut the Complexity: From Cumbersome Legacy Systems to Next-Gen Solutions
- Transforming Regulatory Affairs for a Biopharma Leader
- Brexit’s Ripple Effect: Veterinary Safety Reporting in the UK
