If you are involved with Pharmacovigilance Audits or GPvP, you need to read this.
We also offer online courses for GPvP.. ask me for more details manish.kainth@infonetica.net
Raj Bhogal, Head of Regulatory Inspections, R&D Quality Takeda on the topic of 'Pharmacovigilance Inspections' at IFAH held at Le Meridien, Dubai on 16th - 18th December, 2019.
Grounded in personal experience and expertise as a Trial Manager at Sponsors managing outsourced clinical trials, and as a CRO Trial Manager, this overview presentation builds on this background with the current landscape of managing trials for quality using an extended team.
This is one session in the 1-2 day course I teach on CRO-Clinical Vendor Management that includes Quality by Design and Quality Oversight of your vendors.
This course is provided to Sponsors and CROs who use sub-contractors for their client work.
Pharmacovigilance Audits: Is the USA behind the curve?Medpace
Key takeaways from this presentation are:
•The recognition of the importance of Pharmacovigilance Audits
•To influence the industry to see Pharmacovigilance audits as an effective tool in drug development
If you are involved with Pharmacovigilance Audits or GPvP, you need to read this.
We also offer online courses for GPvP.. ask me for more details manish.kainth@infonetica.net
Raj Bhogal, Head of Regulatory Inspections, R&D Quality Takeda on the topic of 'Pharmacovigilance Inspections' at IFAH held at Le Meridien, Dubai on 16th - 18th December, 2019.
Grounded in personal experience and expertise as a Trial Manager at Sponsors managing outsourced clinical trials, and as a CRO Trial Manager, this overview presentation builds on this background with the current landscape of managing trials for quality using an extended team.
This is one session in the 1-2 day course I teach on CRO-Clinical Vendor Management that includes Quality by Design and Quality Oversight of your vendors.
This course is provided to Sponsors and CROs who use sub-contractors for their client work.
Pharmacovigilance Audits: Is the USA behind the curve?Medpace
Key takeaways from this presentation are:
•The recognition of the importance of Pharmacovigilance Audits
•To influence the industry to see Pharmacovigilance audits as an effective tool in drug development
This Risk Based Monitoring - Impact on Sites overview presentation, on targeted topics, was delivered to the ACRP Raleigh - Durham Chapter's Annual Conference in 2013.
The World Congress Summit on Risk-Based Monitoring and the Quality Risk Manag...WorldCongress
This Summit offers pharmaceutical and medical device delegates concrete examples of how to build a framework and methodology for a risk-based monitoring (RBM) program that is part of an overall risk management approach to study planning and oversight. One of the biggest challenges of implementation is overcoming resistance to change as no organization wants to be the first. For that reason, Summit faculty share change management strategies for people, processes, and technology that led to the effective implementation of their RBM programs. The Site’s perspective, assessing readiness for change and providing support during the change process must not be overlooked. Strategies to partner with Sites to achieve stronger connectivity will also be discussed.
The PV audit ensures that a company’s drug safety and pharmacovigilance operations comply with applicable laws, regulations and guidances worldwide, and compare to best practices for organizations of similar size.
The State of Clinical Outsourcing: Managing Risk in Outsourced Clinical Trials
Interactive Discussion Based on Data from Avoca’s 2013 Industry Research DIA Forum
June 24, 2013
Test status reports communications are sent out to establish transparency during the test cycle.
The Engineering team, Support team, Business Dev team, and the Project Management team are the recipients.
CRO/Vendor oversight should support sponsor regulatory requirements and cost containment.Quality Management in clinical operations are Centralized Monitoring, Study Quality Metrics and CRO Oversight.
The Risk-Based Monitoring (RBM) discussion is moving away from one focused on changing monitoring methods and reducing source document verification (SDV) to 'intelligent monitoring.' Learn why here!
Tips and Tricks on how to go about certifying yourself quickly for the Quality Payment Program in 2018. How does it impact workflow, security and means to accelerate certification.
Effective risk management needs effective risk identification, assessment, planning, tracking and controlling in Clinical Trials. Considering the importance of risk management in efficient management of clinical trials, this webinar by DDismart will provide more insight on Clinical RBM.
Expanding Patient Enrollment and Site Activation Study Case Study: Partnershi...Covance
Clinical development services are often only partially outsourced. Some sponsors prefer to manage the trial themselves due to an affinity for the science involved or perception that the trial's complexity is better handled internally. For this reason, a flexible partner is ideal to ensure the sponsor's needs are being met efficiently and effectively.
Implementing MDSAP (Medical Device Single Audit Program) for Compliance SuccessGlobalCompliancePanel
Reviewing the most significant changes affecting medical device standards and guidance documents, Understanding the MDSAP (goals and strategy), Analyzing the MDSAP main differences with standard auditing, Understanding grading of MDSAP non-conformances
David cocker feasibility_and_web_miningDavid Cocker
Feasibility studies aim to objectively and rationally uncover the strengths and weaknesses of existing resources required to carry through, and ultimately predict the prospects for success
Can software do the hard work for you.
Clinical evaluation and the latest 2016 guidelineGRCTS
This “General Guidance” document promotes a common approach to clinical evaluation for "medical devices regulated by directives 90/385/EEC and 93/42/EEC. It does not concern in vitro diagnostic devices. The depth and extent of clinical evaluations should be flexible and appropriate to the nature, intended purpose, and risks of the device in question.
This Presentation is about why CRO/Vendor oversight should support sponsor regulatory requirements and cost containment.
Topics covered:
1.Importance of CRO/Vendor oversight in clinical trial management.
2. Identify the ways to integrate a risk-based approaches to CRO/Vendor oversight.
3. Developing a CRO/Vendor oversight plan with appropriate KPIs/metrics to be measured.
4. Use of tools and technology for accurate and timely reporting.
This Risk Based Monitoring - Impact on Sites overview presentation, on targeted topics, was delivered to the ACRP Raleigh - Durham Chapter's Annual Conference in 2013.
The World Congress Summit on Risk-Based Monitoring and the Quality Risk Manag...WorldCongress
This Summit offers pharmaceutical and medical device delegates concrete examples of how to build a framework and methodology for a risk-based monitoring (RBM) program that is part of an overall risk management approach to study planning and oversight. One of the biggest challenges of implementation is overcoming resistance to change as no organization wants to be the first. For that reason, Summit faculty share change management strategies for people, processes, and technology that led to the effective implementation of their RBM programs. The Site’s perspective, assessing readiness for change and providing support during the change process must not be overlooked. Strategies to partner with Sites to achieve stronger connectivity will also be discussed.
The PV audit ensures that a company’s drug safety and pharmacovigilance operations comply with applicable laws, regulations and guidances worldwide, and compare to best practices for organizations of similar size.
The State of Clinical Outsourcing: Managing Risk in Outsourced Clinical Trials
Interactive Discussion Based on Data from Avoca’s 2013 Industry Research DIA Forum
June 24, 2013
Test status reports communications are sent out to establish transparency during the test cycle.
The Engineering team, Support team, Business Dev team, and the Project Management team are the recipients.
CRO/Vendor oversight should support sponsor regulatory requirements and cost containment.Quality Management in clinical operations are Centralized Monitoring, Study Quality Metrics and CRO Oversight.
The Risk-Based Monitoring (RBM) discussion is moving away from one focused on changing monitoring methods and reducing source document verification (SDV) to 'intelligent monitoring.' Learn why here!
Tips and Tricks on how to go about certifying yourself quickly for the Quality Payment Program in 2018. How does it impact workflow, security and means to accelerate certification.
Effective risk management needs effective risk identification, assessment, planning, tracking and controlling in Clinical Trials. Considering the importance of risk management in efficient management of clinical trials, this webinar by DDismart will provide more insight on Clinical RBM.
Expanding Patient Enrollment and Site Activation Study Case Study: Partnershi...Covance
Clinical development services are often only partially outsourced. Some sponsors prefer to manage the trial themselves due to an affinity for the science involved or perception that the trial's complexity is better handled internally. For this reason, a flexible partner is ideal to ensure the sponsor's needs are being met efficiently and effectively.
Implementing MDSAP (Medical Device Single Audit Program) for Compliance SuccessGlobalCompliancePanel
Reviewing the most significant changes affecting medical device standards and guidance documents, Understanding the MDSAP (goals and strategy), Analyzing the MDSAP main differences with standard auditing, Understanding grading of MDSAP non-conformances
David cocker feasibility_and_web_miningDavid Cocker
Feasibility studies aim to objectively and rationally uncover the strengths and weaknesses of existing resources required to carry through, and ultimately predict the prospects for success
Can software do the hard work for you.
Clinical evaluation and the latest 2016 guidelineGRCTS
This “General Guidance” document promotes a common approach to clinical evaluation for "medical devices regulated by directives 90/385/EEC and 93/42/EEC. It does not concern in vitro diagnostic devices. The depth and extent of clinical evaluations should be flexible and appropriate to the nature, intended purpose, and risks of the device in question.
This Presentation is about why CRO/Vendor oversight should support sponsor regulatory requirements and cost containment.
Topics covered:
1.Importance of CRO/Vendor oversight in clinical trial management.
2. Identify the ways to integrate a risk-based approaches to CRO/Vendor oversight.
3. Developing a CRO/Vendor oversight plan with appropriate KPIs/metrics to be measured.
4. Use of tools and technology for accurate and timely reporting.
Lightspeed Connect - Niels de Peuter - Mempay - "Hoe kan ik een abonnementsmo...Lightspeed
Abonnementen, in de Verenigde Staten al een aantal jaar de snelst groeiende trend in e-commerce. Maar wat houdt een abonnementsmodel nou eigenlijk in? En hoe pas ik dit toe in mijn webwinkel? Welke uitdagingen kan ik verwachten en hoe ga ik hiermee om? In deze workshop van 30 minuten word je voorbereid om te starten met jouw abonnementsmodel!
“Pharmaceutical Quality Matrices in determining overall state of Quality and ...Marcep Inc.
Introduction to Quality Matrices
•What is Quality metrics
Background&Glossary
•Modernization of Regulatory Oversight of Drug Quality and Promotion of Post-Approval Improvements
•Use of Quality Metrics by FDA for Risk-Based Inspection Scheduling and Prediction of Drug Shortages
Legal authority
•Records Associated with the Process Validation Lifecycle and PQS Assessment
•Authority to Inspect Records and Request in Advance of or In Lieu of an Inspection
The Use of Quality Metrics and Effect of Non-Reporting
•How FDA Intends to Use Quality Metrics
•Effect of Non-Reporting
Group Discussion:
Implementing Trending of Quality Indices in Your Organization
The importance of the right culture and people
• Role of leadership in trending of Quality Indices
• Developing anonline data base for Quality Indices
•Analysis, interpretation and reporting of Quality Indices
The Process Flow
• Establishing the ground rules, procedures, forms and mechanismfor data collection for Quality indices
• Determining responsibilities and roles for the implementation of trending of Quality Indices
Starting the Quality Indices Management Process
•Review of Quality Indices and Gap evaluation
•Preparation of Data bases for Data acquisition
•Collection data for completeness and Accuracy
•Processing and Reporting of Quality Metrics
Day Two
Reporting of Quality data and Calculation of Quality Metrics
• Who Reports and Who May Contribute to the Report
• Quality Metrics that FDA Intends to Calculate
• What Quality Data Would Be Reported
• How to Report Quality Data to FDA
Instructions for Quality Metric Data Submission
•Worksheet for Data Tables
•Product Specific Information
•Mandatory Data •ICH Q9
•Optional Metrics
Recognizing and Understanding the Trending of Quality Indices
Working Session, I:
•Participants will be divided into groups and given acase study and be asked to perform a trend analysis on a given data. Each group will present theresults of its analysis
Working Session II:
•Participants will be divided into groups and given acase study and be asked to perform a trend analysis and propose a Quality metric by using Risk Based approach for the specific set of data. The results of the analyses willbe shared in the class.
Complexities of Implementation Quality Metrics
•Overcoming the pitfalls
•Benefits and Risks
General Discussion and Questions
Product Complaints: Complaint Handling from Intake to ClosureGRCTS
Overview :
An effective complaint handling system is an extremely important part of any quality system whether you are a medical device or pharmaceutical manufacturer. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken. Manufacturers must ensure that they have a well-designed system to address complaints related to their products. Components of a well-designed system include: process/procedure, trained personnel, and proper record keeping. Complaint handling is no easy task. Management might overlook the importance of customer feedback and be unable to capture all complaints coming from disparate sources. Plus, the additional regulatory reporting requirement related to adverse events may seem overly burdensome to device makers in particular. A strategic risk-based methodology can help streamline the complaint-handling process in medical device manufacturing.
Transforming Pharmacovigilance from Operational to Scientifically DrivenVeeva Systems
Learn how scientifically driven pharmacovigilance can enable safety teams to provide faster, more comprehensive benefit-risk assessment to improve patient’s lives. Watch the on-demand webinar: https://go.veeva.com/transforming-pv
Why should you attend:
Understand Verification and Validation, differences and how they work together
Develop a "Working Definition" of V&V, Qualification, and related terms
Discuss recent regulatory expectations
Software Verification & Validation requirements of the FDA and ISO.
The latest FDA Software Guidance & Regulations, including Part 11 -impact on V&V strategies
Device and Manufacturing software requirements for V & V
How to determine & demonstrate an appropriate V & V strategy
How to determine & handle software for different Levels of Concern
What V&V is required for 3rd Party software-custom and Off-the-shelf
Impact of FDA, Mobile APPS, Cyber Security, and software standards such as IEC 62304
What to look for during software vendor audits.
V & V documentation and level of detail required for device submissions.
How to document a "risk-based" rationale, and use it in a resource-constrained environment
Determine key "milestones" and "tasks" in a project as well as discussing audience related projects for discussion points
1. Summary of Pharmacovigilance (PV) Expertise and Experience
Department
startup & strategic
process
improvement:
PV department design, job descriptions, and outsourcing strategy
Establishment of PV internal interfaces (e.g., Clinical, Medical
Affairs, Marketing, HOER, Quality) and safety governance, call
center start up
Adverse event collection, processing, and reporting procedures
Process improvement and tools for case management,
PBRER/DSUR development
Risk management plan integration
Global expansion/
product launch:
Cross-departmental gap analysis and implementation of global
regulations including EMA GVP
Affiliate PV department creation including allocation of PV tasks,
integration with headquarters (HQ), SOP strategy, and call center
selection and start up
PV quality system: SOP strategy, development, and training
Inspection readiness evaluation, preparation, and site support
PV department, call center, and vendor audits
CAPA root cause analysis, remediation, and management
Compliance and quality metrics for ICSRs and periodic reports
License partner
liaison:
Standard Safety Data Exchange Agreement (SDEA) templates
SDEA negotiation, finalization, and implementation
License partner management and compliance monitoring
Outsourcing: Outsourcing strategy, RFP development, and vendor selection
Vendor start up and on-going management
Tools for ICSR and periodic report quality management
Clinical and post-
marketing
programs:
Safety reporting requirements definition and standard language for
protocols, investigator-initiated research (IIR), and vendor contracts
Safety Management Plan templates and documentation of PV
responsibilities and flow of safety information for study start-up
PV operations
project
management:
Business requirements for database selection, customization and/or
configuration; database implementation project management
Manage PBRER/DSUR development