IVDR’s Summary of Safety and Performance
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Delve into IVDR's Summary of Safety and Performance for crucial insights and compliance essentials. Stay informed with our concise guide. The world of in vitro diagnostics is all about accuracy and reliability. EU IVDR includes a requirement to write a Summary of Safety and Performance (SSP) for Class C and D IVDs. The goal is to emphasise transparency and provide adequate public access to summarise the data on safety and performance to patients and intended users, which includes both professionals and lay people where applicable. https://mavenprofserv.com/understanding-the-ivdr-summary-of-safety-and-performance/
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PHARMACOVIGILANCE COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS-Updated IN 202...
PHARMACOVIGILANCE COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS-Updated IN 202...Pristyn Research Solutions
Quick Job interview short guide For Pharma and all Life science jobseekers.All Medical | Biotech |Micro |B.Sc., M.Sc.
These are the commonly asked questions with their answers asked in job interviews. The file was updated in 2022.
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1) Parmar Trade Centre, A-wing,105/106, Sadhu Vaswani Chowk, Pune, 411001. Email: info@pristynresearch.com Phone: 09028839789
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Sample Questions are:
What is Pharmacovigilance (PV)?
What are the objectives of PV?
What is MedDRA?
WHAT ARE THE Role of Drug Safety
Associate?
What should narratives consist of?
What are Data assessments in PV?
Which products are covered by PV?
Methods of signal detection?
Why PV is required after clinical
trial?
What is an Adverse Drug Event (ADE)?
What
is the minimum criterion required
for a valid case according to WHO?
When
do you consider an event to be
serious?
What do you mean by causality?
Types of
Unsolicited reports
Sources of Solicited Reports
Name the core regulatory bodies
What is Volume 9A
What do you know
about E2a, E2b and E2c guidelines?
When do you consider a case to be medically confirmed?
What is CemFlow?
What is the yellow card in PV?
What are Comorbid conditions?
What is a medication error?
What is a signal?
Rechallenge
Dechallenge
What are WHO ART, WHO DD and MedDRA and the difference between them?
What is SUSAR?
Adverse Drug Reaction (ADR)
Effectiveness/risk
harm
Essential medicines
Frequency of ADRs
Individual Case Safety Report
ADR Reporting process in PV
VigiFlow
VigiMed
ABBOTTS
COGNIZANT
I 3 GLOBAL DRUG
SAFETY
LAURUS LABS
PARAXEL
SRISTEK
ACCENTURE
CREST.
I GATE PATNI
COMPUTERS
MAHINDRA
SATYAMBSG
PIRAMAL
SUN
PHARMA
ALEMBIC
DIAGNOSEAR
CH
ICON
MAKROCARE
PPD
SYMOGEN
APC PHARMA.
DR REDDY’S
iMEDGlobal,
MANKIND
QUANTUM
SOLUTIONS
SYNOGEN
APCER
ECRON
ACUNOVA
IMS HEALTH
MEDHIMALAYAS
QUINTILES
TAKE
SOLUTIONS
APCER
EMCURE
INC RESEARCH
MEDPACE.
SCIFORMIX
RATIOPHARM
TCS
ASTRAZENECA
FDC
Infocorp
Soft
Solutions
MICRO LABS
RX MD
THOMSON
REUTERS
AUROBINDO
FORTIS
HEALTH CARE
INVENTIVE
MSD (MERCK)
SANTHA
BIOTECH
USV
LIMITED
BESTOCHEM
G7 INFOTECH
IPCA
LABORATORIES
NEKTAR
THERAPEUTICS
SCIFORMIX.
VIMTA LABS
BIOCAD
GENPACT
IPLEX
NORWICH
CLINICAL SERVICES
SHANTHA
BIOTECHNICS
WIPRO
BIOCON
GRANULES
JUBILIANT
BIOSYS NOVARTIS
SIRO
CLINPHARM
WNS
BIOLOGICAL E.
LTD
GVK
KINAPSE
NOVO NORDISK
SP softtech
WOCKHARD
T
BLUEFISH
HCL
LAMBDA
OMNICARECLINICA
L RESEARCH
SRI KRISHNA
PHARMA
4C
Pharma
SolutionsImplementation of Clinical Nursing Module - report
The document discusses implementing the VistA Nursing electronic health record (EHR) module at Jawaharlal Nehru Polytrauma and Burn Centre (JPNATC) in New Delhi, India. It begins with an organizational profile of JPNATC and describes the existing EHR system. It then outlines the objectives, methodology, and implementation process, which includes process mapping, gap analysis, customizing templates, user testing, and training. The discussion section analyzes gaps between current and VistA Nursing workflows. Recommendations include creating new templates to standardize nursing documentation and registers.
Cataract Audit as part of Workflow
This document discusses using cataract surgery audit data captured as part of normal workflow to analyze outcomes and refine surgical processes. The data is captured in separate pre-operation, operation, and post-operation templates that tell the story of the cataract operation. The audit data from over 70 data points across different clinics and countries can be used for population research, refining surgical processes, and auditing surgeons. Standards are needed for defining data elements and expressing the data to allow international benchmarking and interoperability.
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The key differences between the MDR and IVDR in the EU
In the European Union (EU), two significant regulations have been introduced to enhance the safety and effectiveness of medical devices – the In Vitro Diagnostic Regulation (IVDR) and the Medical Device Regulation (MDR).
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The Medical Device Single Audit Program (MDSAP) is a harmonised approach to auditing and monitoring the quality management systems of medical device manufacturers on an international scale. The purpose of MDSAP is to establish, conduct and command a single audit program. This allows a single audit of a medical device manufacturer’s QMS which satisfies the requirements of multiple regulatory jurisdictions.
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MDSAP
MDSAP is a technique through which medical device makers may be inspected once for conformity with the different medical device markets standards and regulatory requirements. Multiple individual audits or inspections by participating regulatory bodies or their representatives are replaced by a single audit. As a result, the Medical Device Single Audit Program minimizes the overall number of audits or inspections and optimises the time and resources spent on audit operations for many medical device manufacturers.
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Medical device manufacturers in Australia related to the Demonstration of Equivalence is important for regulatory compliance and ensuring the safety and effectiveness of medical devices. Demonstrating equivalence is a crucial step in the regulatory process, as it helps establish that a new device is similar in safety and performance to a previously approved device. One of the key requirements for gaining approval for a medical device in Australia is demonstrating equivalence. This process involves showing that the new device is equivalent to a previously approved reference device in terms of safety, quality, and performance.
https://mavenprofserv.com/demonstration-of-equivalence/
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A Clinical Evaluation Plan is a critical document in the medical device regulatory process, outlining how you will gather and evaluate clinical data to demonstrate the safety and performance of your medical device. In Australia, medical devices are regulated by the Therapeutic Goods Administration. Additionally, consider consulting with regulatory experts or legal counsel experienced in medical device regulations in Australia to ensure compliance with the local regulatory framework.
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IVDR’s Summary of Safety and Performance
- 1. IVDR’s Summary of Safety and Performance (SSP) W W W . M A V E N P R O F S E R V . C O M
- 2. O v e r v i e w Ensuring Compliance: Understanding The IVDR’s Summary Of Safety And Performance (SSP) What Is Summary Of Safety And Performance (SSP)? Why Is Summary Of Safety And Performance (SSP) Important? What Resources Are Required For Summary Of Safety And Performance (SSP) Preparation? What Languages Should The Summary Of Safety And Performance (SSP) Provide?
- 3. Ensuring Compliance: Understanding The IVDR’s Summary Of Safety And Performance (SSP) The world of in vitro diagnostics is all about accuracy and reliability. EU IVDR includes a requirement to write a Summary of Safety and Performance (SSP) for Class C and D IVDs. The goal is to emphasize transparency and provide adequate public access to summaries the data on safety and performance to patients and intended users, which includes both professionals and lay people where applicable
- 4. This post will unpack the Summary of Safety and Performance (SSP), explaining what it is, why it matters, and what it contains.
- 5. What Is Summary Of Safety And Performance (SSP)? The world of in vitro diagnostics is all about accuracy and reliability. EU IVDR includes a requirement to write a Summary of Safety and Performance (SSP) for Class C and D IVDs. The goal is to emphasize transparency and provide adequate public access to summaries the data on safety and performance to patients and intended users, which includes both professionals and lay people where applicable
- 6. The data presented in the Summary of Safety and Performance (SSP) is compiled directly from the technical documentation. EU IVDR requires the Summary of Safety and Performance (SSP) to be validated by a Notified Body (NB), updated annually with new information and made available to the public via EUDAMED.
- 7. Why Is Summary Of Safety And Performance (SSP) Important? It increases transparency by making data on the IVD’s performance publicly available. By having this information readily available, healthcare professionals can make more informed decisions about using IVD in their practice.
- 8. For certain IVDs, the Summary of Safety and Performance (SSP) can empower patients to understand the test better and participate in shared decision-making with their healthcare provider.
- 9. What Resources Are Required For Summary Of Safety And Performance (SSP) Preparation? Summary of Safety and Performance (SSP) relies on already gathered information and technical documentation such as design and development, risk management, performance evaluation, post-market performance follow-up and post- market surveillance.
- 10. MDCG 2022-9 provides guidance for the preparation of the Summary of Safety and Performance (SSP), which has two sections: for devices intended to be used by professionals for devices intended for self-testing
- 11. Summary Of Safety And Performance (SSP) For Devices Not Intended For Self-Testing: It includes two subparts: one for professional users and another for patients/laypersons. If it is decided that a patient version/layperson is not applicable, then a justification must be provided.
- 12. Summary of Safety and Performance (SSP) shall include: Device identification and general information Intended use of the device Device Description Reference to any harmonised standards and CS Risks and warnings Summary of performance evaluation and post-market performance follow-up
- 13. Metrological traceability of assigned values Suggested profile and training for users Revision History Summary of Safety and Performance (SSP) is not intended to replace Instructions for Use as the main document to ensure safe use of the device, nor is it intended to provide diagnostic or therapeutic suggestions to intended users.
- 14. What Languages Should The Summary Of Safety And Performance (SSP) Provide? Summary of Safety and Performance (SSP) should be prepared in languages accepted in the Member states, where the device is to be sold, along with an English version of the document. The language in which the Summary of Safety and Performance (SSP) was validated will be mentioned in the document.