Is Your Portfolio Ready for Data Enrichment?
The EMA has taken a huge step towards IDMP implementation with the go live of the Product Management Service (PMS) and integration of PMS data
Is Your Portfolio Ready for Data Enrichment?
The EMA has taken a huge step towards IDMP implementation with the go live of the Product Management Service (PMS) and integration of PMS data into the e-Application Form (eAF). There are now broader requirements
MHRA consider dramatic changes to the regulation of medical devices and in vitro diagnostics
The MHRA recently closed their consultation on routes to market for medical devices and in vitro diagnostic devices. The consultation, which closed on 5 January 2025, asked for input on international reliance procedures, removing UKCA
eCTD 4.0: Key Milestones
eCTD 4.0 is one of the main focal points of the regulatory world and there has been significant progress over the last year, with some major steps to come in 2025. Ensure you know which
IDMP at the EMA: The European Shortage Monitoring Platform
More than four years after the initial publication of the EMA’s IDMP Implementation Guide in February 2020, the EMA have taken their biggest step towards IDMP implementation yet with the go live of the Product
Why The Future of Pharma Starts with IDMP
The pharmaceutical industry is no stranger to complex regulations and compliance requirements. Among them, the Identification of Medicinal Products (IDMP) standards set by the European Medicines Agency (EMA) stand out for their potential transformative power.
Preparing for eCTD 4.0 Pilots
At Ennov, we have always encouraged participation in Health Authority (HA) pilot schemes for new and emerging technologies. By having an open platform of communication and collaboration we ensure that we, and our clients, can
Brexit’s Ripple Effect: Veterinary Safety Reporting in the UK
Brexit has sent shockwaves through numerous industries, with one of its less publicized but significant impacts being on veterinary safety data reporting. The UK’s departure from the European Union has necessitated the establishment of independent
Cut the Complexity: From Cumbersome Legacy Systems to Next-Gen Solutions
Small and mid-sized life sciences companies face big hurdles. They must follow strict regulations, meet rigorous quality standards, and adapt to rapidly changing digital technologies – all with limited resources compared to industry giants. Legacy
Gartner Insights: Maximize Your QMS Success with Peer Guidance
Implementing a Quality Management System (QMS) software is a pivotal step for any organization aiming to enhance their quality policies and standard operating procedures. Gartner’s recent report, “Peer Lessons Learned for Quality Management System Software
How to Future-Proof MedDevice/MedTech Compliance
The medical device industry is at a pivotal point, grappling with significant regulatory updates like the European Union’s Medical Device Regulation (MDR) or the FDA’s Quality Management System Regulation (QMSR) Final Rule. These regulations enhance
Accelerating Drug Development: Unpacking FDA’s Master Protocol Guidance
In December, FDA issued a draft guidance, Master Protocols for Drug and Biological Product Development. This guidance is currently in the public comment period; comments received to date can be viewed on its Dockets page.
New MoCRA Adverse Event Reporting Requirements: Impact on the Cosmetic Industry
Product safety and consumer protection stand at the forefront of the cosmetics industry, underpinned by regulatory frameworks like the Modernization of Cosmetics Regulation Act of 2022 and its 2023 amendment. These mandates highlight the growing
Is Your Portfolio Ready for Data Enrichment?
The EMA has taken a huge step towards IDMP implementation with the go live of the Product Management Service (PMS) and integration of PMS data into the e-Application Form (eAF). There are now broader requirements
MHRA consider dramatic changes to the regulation of medical devices and in vitro diagnostics
The MHRA recently closed their consultation on routes to market for medical devices and in vitro diagnostic devices. The consultation, which closed on 5 January 2025, asked for input on international reliance procedures, removing UKCA
eCTD 4.0: Key Milestones
eCTD 4.0 is one of the main focal points of the regulatory world and there has been significant progress over the last year, with some major steps to come in 2025. Ensure you know which
IDMP at the EMA: The European Shortage Monitoring Platform
More than four years after the initial publication of the EMA’s IDMP Implementation Guide in February 2020, the EMA have taken their biggest step towards IDMP implementation yet with the go live of the Product
Why The Future of Pharma Starts with IDMP
The pharmaceutical industry is no stranger to complex regulations and compliance requirements. Among them, the Identification of Medicinal Products (IDMP) standards set by the European Medicines Agency (EMA) stand out for their potential transformative power.
Preparing for eCTD 4.0 Pilots
At Ennov, we have always encouraged participation in Health Authority (HA) pilot schemes for new and emerging technologies. By having an open platform of communication and collaboration we ensure that we, and our clients, can
How to Future-Proof MedDevice/MedTech Compliance
The medical device industry is at a pivotal point, grappling with significant regulatory updates like the European Union’s Medical Device Regulation (MDR) or the FDA’s Quality Management System Regulation (QMSR) Final Rule. These regulations enhance
The Future of Medical Device Regulation: Insights from Ennov’s Expert Working Group
In an era where medical device regulation is becoming increasingly complex, the importance of robust regulatory compliance cannot be overstated. It’s a critical component that signifies not just adherence to legal standards, but also a
The RAP Up: Trends from 2023 RAPS Convergence
Now that we’re back from the RAPS Convergence in Montreal, I thought I’d share what stood out to me. While a number of interesting topics were discussed, what piqued my interest most was a rather
Navigating IDMP Compliance: The Time is Now
Navigating IDMP compliance can feel like an intricate puzzle with evolving guidelines, shifting timelines, and the complexities of data integration. Regardless, did you know, 41% of organizations are already actively preparing for IDMP/SPOR? Our infographic
The Future of Regulatory Affairs: Decoding the 2023 RAPS Convergence Agenda
As Life Science professionals, we often find ourselves at the crossroads of scientific innovation, compliance, and strategic business initiatives. Yet, how often do we pause to consider the transformative shifts that are reshaping our industry?
Gartner Insights: IDMP & EMA Compliance
Navigating the labyrinth of pharmaceutical industry regulations, such as the Identification of Medicinal Products (IDMP) and European Medicines Agency (EMA) directives, demands an informed and authoritative approach. The challenge lies in understanding and efficiently managing
Cut the Complexity: From Cumbersome Legacy Systems to Next-Gen Solutions
Small and mid-sized life sciences companies face big hurdles. They must follow strict regulations, meet rigorous quality standards, and adapt to rapidly changing digital technologies – all with limited resources compared to industry giants. Legacy
Gartner Insights: Maximize Your QMS Success with Peer Guidance
Implementing a Quality Management System (QMS) software is a pivotal step for any organization aiming to enhance their quality policies and standard operating procedures. Gartner’s recent report, “Peer Lessons Learned for Quality Management System Software
The New Wave of QMS [8/8]: Reflections & Looking Ahead
The horizon for Quality Management Systems (QMS) is brimming with opportunities, ready to revolutionize the Life Sciences field. As we conclude our blog series on the future of QMS, let’s cover the takeaways. Retrospection: The
The New Wave of QMS [7/8]: Cybersecurity Measures
In today’s digitally-driven era, data plays a paramount role in shaping the trajectory of the Life Sciences industry. As organizations increasingly rely on digital tools and platforms for quality management, the sheer volume of sensitive
The New Wave of QMS [6/8]: Flexibility & Adaptability
The Life Sciences sector, by its very nature, is in a state of continual evolution. Innovations in research, shifts in market dynamics, and alterations in regulatory landscapes mean that static systems and processes can quickly
The New Wave of QMS [5/8]: User-Centric Interface
The global nature of the Life Sciences industry brings with it an inherent diversity—geographically spread teams, a variety of roles, and a broad range of technical expertise levels. Amidst this decentralization and diversity, the importance
The New Wave of QMS [4/8]: Data-Driven Decisions
In today’s digitized world, data is often termed as the “new oil.” The Life Sciences industry, rich in complex processes and critical operations, generates vast amounts of data. But what’s more important than just collecting
The New Wave of QMS [3/8]: Scalability
In the evolving landscape of the Life Sciences industry, growth and diversification are constants. From expanding into new markets, and developing innovative products, to integrating cutting-edge technologies, growth can take many forms. Amidst these advancements,
The New Wave of QMS [2/8]: Comprehensive Integration
In an era marked by rapid technological advancements and increasingly interconnected business ecosystems, the call for seamless integration in Quality Management Systems (QMS) has become not just a desire but a necessity. The ability for
The New Wave of QMS [1/8]: Setting the Stage for Modern Quality Management
In the Life Sciences industry, Quality Management Systems (QMS) serve as the cornerstone for ensuring product integrity, compliance with stringent regulations, and ultimately, patient safety. The landscape of QMS has seen tremendous changes, evolving through
Empower Your Quality Management Journey with Gartner Market Guide Insights
The Quality Management System (QMS) landscape is continually transforming, driven by innovative technologies and emerging trends. Discover the essential insights from Gartner’s latest Market Guide for Quality Management System Software and learn how to harness
Ennov’s Secret to Consistent Quality
As a leading software company that provides innovative solutions to the life sciences, healthcare, and other regulated industries, we at Ennov understand the importance of maintaining a high level of quality across all aspects of
Accelerating Drug Development: Unpacking FDA’s Master Protocol Guidance
In December, FDA issued a draft guidance, Master Protocols for Drug and Biological Product Development. This guidance is currently in the public comment period; comments received to date can be viewed on its Dockets page.
Navigating Certified Copies: A Global Guide to FDA, EMA, and Beyond
The clinical trial industry is constantly evolving, with electronic Trial Master Files (eTMF) becoming increasingly popular among sponsors and CROs. By reducing the need for paper documents and streamlining processes, eTMFs can help save time,
How Mobile EDC is Transforming Clinical Trials in 2023
Electronic Data Capture (EDC) has become an essential part of clinical trials, providing a more efficient way to collect, manage and analyze data. Mobile EDC applications, which can be run on tablets or mobile devices,
TMF Completeness: From Chaos to Order
TMF completeness findings are the most commonly reported inspection findings. For example, in them most recently published MHRA GCP inspection report , there were twice as many findings in this category than in the next
5 Myths About eTMF
Managing eTMF (electronic trial master file) is a challenge. However, some organizations impose burdens upon themselves by following practices that aren’t consistent with Health Authority guidance. In this blog article, I look at common misconceptions and provide
The Journey to Risk-Based Clinical Analytics
Read the White Paper: Clinical Analytics: The Journey from Problem Identification to Solution Encouraged by Health Authorities, Life Sciences organizations have moved towards risk-based approaches in almost all of their activities. To support a true
Archiving a CRO-Generated eTMF: Considerations for Sponsors
Summary Sponsors receiving TMFs from CRO partners at the end of a study often experience quality issues when attempting to archive the TMFs. This post provides recommendations for sponsors to help ensure that the TMF
MHRA Trial Master File (TMF) GCP Inspection Findings: Trends and Takeaways
On February 12, 2021, The UK Medicines & Healthcare Products Regulatory Agency (MHRA) published their annual GCP Inspections Metrics Report. This report covered the period from 1 April 2018 to 31 March 2019. For an
Clinical CAPAs: Are Your Trials in a State of Control?
The MHRA Inspectorate Blog recently posted a post [i] discussing Corrective and Preventive Actions, the importance of root cause analysis, and what triggers inspectors to believe that a quality system is not in a state
FDA Issues Final Guidance on Civil Money Penalties Relating to ClinicalTrials.gov
FDA has issued a final guidance document on Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank. This draft guidance was first issued in 2018 and has been revised with industry comments. Section 303(f)(3) of
Optimize Your eTMF Strategy
I have recently published a peer-reviewed paper called “Optimize Your eTMF Strategy”, that you can read or download on the Journal for Clinical Studies (Volume 11, Issue 11). I wanted to give you in this
6 Considerations for Selecting an EDC Solution
Electronic Data Capture (EDC) solutions have been used for a couple of decades now with more systems available today than one can count. From the big, well-known EDC providers, to the small not so well
Brexit’s Ripple Effect: Veterinary Safety Reporting in the UK
Brexit has sent shockwaves through numerous industries, with one of its less publicized but significant impacts being on veterinary safety data reporting. The UK’s departure from the European Union has necessitated the establishment of independent
3 Steps to Signal Detection in Pharmacovigilance
There is a growing emphasis on signal detection and signal management in Pharmacovigilance. Companies must be able to manage signals detected: evaluate them to understand the clinical risk in light of multiple impacting factors, in
Smart Signal Management in Pharmacovigilance
The evaluation of safety signals should be a continuous process in pharmacovigilance and it is essential that Manufacturing Authorization Holders (MAH’s) have a well-defined process to capture, evaluate, communicate and take action on potential PV risks, as needed.
FDA Guidance on Post-marketing Adverse Event Reporting During a Pandemic
The FDA has issued a formal guidance document providing recommendations to industry regarding post-marketing adverse event reporting for drugs, biologics, medical devices, combination products, and dietary supplements during a pandemic. FDA anticipates that during a pandemic,
Ennov PV – An Auto-Testing Revolution
[Reading time 5 minutes] Acceptance testing has always been an important part of our lives at Ennov PV. Understandably, our customers have high expectations with respect to quality in the products that we deliver. Pharmacovigilance
EudraVigilance Update, GVP Module IX, and the Impact on Signal Detection
With the release of the new Eudravigilance system on 22nd November 2017, the European Medicines Agency (EMA) have introduced greater access to adverse event data stored in the central repository. Furthermore, on the same day
Our Journey with Scrum
[Reading time 10-15 minutes] As we approach our first eighteen months of using the Agile Scrum methodology at Ennov PV, it seems a good time to reflect on our journey so far. It’s pretty obvious
New MoCRA Adverse Event Reporting Requirements: Impact on the Cosmetic Industry
Product safety and consumer protection stand at the forefront of the cosmetics industry, underpinned by regulatory frameworks like the Modernization of Cosmetics Regulation Act of 2022 and its 2023 amendment. These mandates highlight the growing
Why Unified Platforms are the Future of Cosmetovigilance
In an industry where innovation meets stringent safety requirements, cosmetovigilance (CV) stands as the critical backbone of consumer protection and brand integrity. The enactment of the EU Cosmetics Regulation 1223/2009 has brought about a renewed focus on
Dermatological Safety Assurance with Unified Platforms
The Challenge In the pursuit of dermatological excellence, maintaining the integrity of safety data is not merely an option; it is the bedrock of consumer trust. Companies bear the critical responsibility of overseeing product safety,
The Trust Equation: Safety, Branding, and Consumer Loyalty
In ethical skincare, the challenge is balancing safety, brand values, and consumer loyalty. Companies must align products with values, meet global safety standards, and navigate complexity during innovation and expansion. Consistent regulatory compliance and consumer
Holistic Beauty and Safety Compliance: Bridging the Gap
In holistic skincare, marrying natural wellness with global safety standards is challenging. Companies must ensure products are effective and safe while complying with diverse regulations in expanding markets. This balance is vital for brand integrity
Sustainability in Safety: The Cosmetovigilance Approach
In the organic skincare sector, balancing safety and sustainability is a challenge. Companies must meet strict safety standards while innovating eco-friendly products and navigating global regulations. Managing safety data sustainably, maintaining transparency, and building trust
Streamlining Operations with Digital Cosmetovigilance
In dermatology and aesthetic medicine, operational efficiency is vital. Companies must manage safety data efficiently, uphold product safety, and streamline operations to innovate faster while meeting global safety regulations. Scaling globally intensifies this challenge.
Strategic Safety Data Management for Cosmetic Compliance
The cosmetics industry is constantly changing, making safety data management a unique challenge. To adhere to global regulations, cosmetic companies need a versatile Cosmetovigilance (CV) system that evolves with the market. Choosing the right CV partner goes
Regulatory Compliance in the Cosmetics Industry
The cosmetics industry is subject to a complex array of regulatory frameworks that vary significantly across regions. In North America, for example, the FDA governs cosmetics under the Federal Food, Drug, and Cosmetic Act, which
Is Your Portfolio Ready for Data Enrichment?
The EMA has taken a huge step towards IDMP implementation with the go live of the Product Management Service (PMS) and integration of PMS data into the e-Application Form (eAF). There are now broader requirements
MHRA consider dramatic changes to the regulation of medical devices and in vitro diagnostics
The MHRA recently closed their consultation on routes to market for medical devices and in vitro diagnostic devices. The consultation, which closed on 5 January 2025, asked for input on international reliance procedures, removing UKCA
eCTD 4.0: Key Milestones
eCTD 4.0 is one of the main focal points of the regulatory world and there has been significant progress over the last year, with some major steps to come in 2025. Ensure you know which
IDMP at the EMA: The European Shortage Monitoring Platform
More than four years after the initial publication of the EMA’s IDMP Implementation Guide in February 2020, the EMA have taken their biggest step towards IDMP implementation yet with the go live of the Product
Why The Future of Pharma Starts with IDMP
The pharmaceutical industry is no stranger to complex regulations and compliance requirements. Among them, the Identification of Medicinal Products (IDMP) standards set by the European Medicines Agency (EMA) stand out for their potential transformative power.
Preparing for eCTD 4.0 Pilots
At Ennov, we have always encouraged participation in Health Authority (HA) pilot schemes for new and emerging technologies. By having an open platform of communication and collaboration we ensure that we, and our clients, can
Brexit’s Ripple Effect: Veterinary Safety Reporting in the UK
Brexit has sent shockwaves through numerous industries, with one of its less publicized but significant impacts being on veterinary safety data reporting. The UK’s departure from the European Union has necessitated the establishment of independent
Cut the Complexity: From Cumbersome Legacy Systems to Next-Gen Solutions
Small and mid-sized life sciences companies face big hurdles. They must follow strict regulations, meet rigorous quality standards, and adapt to rapidly changing digital technologies – all with limited resources compared to industry giants. Legacy
Gartner Insights: Maximize Your QMS Success with Peer Guidance
Implementing a Quality Management System (QMS) software is a pivotal step for any organization aiming to enhance their quality policies and standard operating procedures. Gartner’s recent report, “Peer Lessons Learned for Quality Management System Software
How to Future-Proof MedDevice/MedTech Compliance
The medical device industry is at a pivotal point, grappling with significant regulatory updates like the European Union’s Medical Device Regulation (MDR) or the FDA’s Quality Management System Regulation (QMSR) Final Rule. These regulations enhance
Accelerating Drug Development: Unpacking FDA’s Master Protocol Guidance
In December, FDA issued a draft guidance, Master Protocols for Drug and Biological Product Development. This guidance is currently in the public comment period; comments received to date can be viewed on its Dockets page.
New MoCRA Adverse Event Reporting Requirements: Impact on the Cosmetic Industry
Product safety and consumer protection stand at the forefront of the cosmetics industry, underpinned by regulatory frameworks like the Modernization of Cosmetics Regulation Act of 2022 and its 2023 amendment. These mandates highlight the growing
Is Your Portfolio Ready for Data Enrichment?
The EMA has taken a huge step towards IDMP implementation with the go live of the Product Management Service (PMS) and integration of PMS data into the e-Application Form (eAF). There are now broader requirements
MHRA consider dramatic changes to the regulation of medical devices and in vitro diagnostics
The MHRA recently closed their consultation on routes to market for medical devices and in vitro diagnostic devices. The consultation, which closed on 5 January 2025, asked for input on international reliance procedures, removing UKCA
eCTD 4.0: Key Milestones
eCTD 4.0 is one of the main focal points of the regulatory world and there has been significant progress over the last year, with some major steps to come in 2025. Ensure you know which
IDMP at the EMA: The European Shortage Monitoring Platform
More than four years after the initial publication of the EMA’s IDMP Implementation Guide in February 2020, the EMA have taken their biggest step towards IDMP implementation yet with the go live of the Product
Why The Future of Pharma Starts with IDMP
The pharmaceutical industry is no stranger to complex regulations and compliance requirements. Among them, the Identification of Medicinal Products (IDMP) standards set by the European Medicines Agency (EMA) stand out for their potential transformative power.
Preparing for eCTD 4.0 Pilots
At Ennov, we have always encouraged participation in Health Authority (HA) pilot schemes for new and emerging technologies. By having an open platform of communication and collaboration we ensure that we, and our clients, can
How to Future-Proof MedDevice/MedTech Compliance
The medical device industry is at a pivotal point, grappling with significant regulatory updates like the European Union’s Medical Device Regulation (MDR) or the FDA’s Quality Management System Regulation (QMSR) Final Rule. These regulations enhance
The Future of Medical Device Regulation: Insights from Ennov’s Expert Working Group
In an era where medical device regulation is becoming increasingly complex, the importance of robust regulatory compliance cannot be overstated. It’s a critical component that signifies not just adherence to legal standards, but also a
The RAP Up: Trends from 2023 RAPS Convergence
Now that we’re back from the RAPS Convergence in Montreal, I thought I’d share what stood out to me. While a number of interesting topics were discussed, what piqued my interest most was a rather
Navigating IDMP Compliance: The Time is Now
Navigating IDMP compliance can feel like an intricate puzzle with evolving guidelines, shifting timelines, and the complexities of data integration. Regardless, did you know, 41% of organizations are already actively preparing for IDMP/SPOR? Our infographic
The Future of Regulatory Affairs: Decoding the 2023 RAPS Convergence Agenda
As Life Science professionals, we often find ourselves at the crossroads of scientific innovation, compliance, and strategic business initiatives. Yet, how often do we pause to consider the transformative shifts that are reshaping our industry?
Gartner Insights: IDMP & EMA Compliance
Navigating the labyrinth of pharmaceutical industry regulations, such as the Identification of Medicinal Products (IDMP) and European Medicines Agency (EMA) directives, demands an informed and authoritative approach. The challenge lies in understanding and efficiently managing
Cut the Complexity: From Cumbersome Legacy Systems to Next-Gen Solutions
Small and mid-sized life sciences companies face big hurdles. They must follow strict regulations, meet rigorous quality standards, and adapt to rapidly changing digital technologies – all with limited resources compared to industry giants. Legacy
Gartner Insights: Maximize Your QMS Success with Peer Guidance
Implementing a Quality Management System (QMS) software is a pivotal step for any organization aiming to enhance their quality policies and standard operating procedures. Gartner’s recent report, “Peer Lessons Learned for Quality Management System Software
The New Wave of QMS [8/8]: Reflections & Looking Ahead
The horizon for Quality Management Systems (QMS) is brimming with opportunities, ready to revolutionize the Life Sciences field. As we conclude our blog series on the future of QMS, let’s cover the takeaways. Retrospection: The
The New Wave of QMS [7/8]: Cybersecurity Measures
In today’s digitally-driven era, data plays a paramount role in shaping the trajectory of the Life Sciences industry. As organizations increasingly rely on digital tools and platforms for quality management, the sheer volume of sensitive
The New Wave of QMS [6/8]: Flexibility & Adaptability
The Life Sciences sector, by its very nature, is in a state of continual evolution. Innovations in research, shifts in market dynamics, and alterations in regulatory landscapes mean that static systems and processes can quickly
The New Wave of QMS [5/8]: User-Centric Interface
The global nature of the Life Sciences industry brings with it an inherent diversity—geographically spread teams, a variety of roles, and a broad range of technical expertise levels. Amidst this decentralization and diversity, the importance
The New Wave of QMS [4/8]: Data-Driven Decisions
In today’s digitized world, data is often termed as the “new oil.” The Life Sciences industry, rich in complex processes and critical operations, generates vast amounts of data. But what’s more important than just collecting
The New Wave of QMS [3/8]: Scalability
In the evolving landscape of the Life Sciences industry, growth and diversification are constants. From expanding into new markets, and developing innovative products, to integrating cutting-edge technologies, growth can take many forms. Amidst these advancements,
The New Wave of QMS [2/8]: Comprehensive Integration
In an era marked by rapid technological advancements and increasingly interconnected business ecosystems, the call for seamless integration in Quality Management Systems (QMS) has become not just a desire but a necessity. The ability for
The New Wave of QMS [1/8]: Setting the Stage for Modern Quality Management
In the Life Sciences industry, Quality Management Systems (QMS) serve as the cornerstone for ensuring product integrity, compliance with stringent regulations, and ultimately, patient safety. The landscape of QMS has seen tremendous changes, evolving through
Empower Your Quality Management Journey with Gartner Market Guide Insights
The Quality Management System (QMS) landscape is continually transforming, driven by innovative technologies and emerging trends. Discover the essential insights from Gartner’s latest Market Guide for Quality Management System Software and learn how to harness
Ennov’s Secret to Consistent Quality
As a leading software company that provides innovative solutions to the life sciences, healthcare, and other regulated industries, we at Ennov understand the importance of maintaining a high level of quality across all aspects of
Brexit’s Ripple Effect: Veterinary Safety Reporting in the UK
Brexit has sent shockwaves through numerous industries, with one of its less publicized but significant impacts being on veterinary safety data reporting. The UK’s departure from the European Union has necessitated the establishment of independent
3 Steps to Signal Detection in Pharmacovigilance
There is a growing emphasis on signal detection and signal management in Pharmacovigilance. Companies must be able to manage signals detected: evaluate them to understand the clinical risk in light of multiple impacting factors, in
Smart Signal Management in Pharmacovigilance
The evaluation of safety signals should be a continuous process in pharmacovigilance and it is essential that Manufacturing Authorization Holders (MAH’s) have a well-defined process to capture, evaluate, communicate and take action on potential PV risks, as needed.
FDA Guidance on Post-marketing Adverse Event Reporting During a Pandemic
The FDA has issued a formal guidance document providing recommendations to industry regarding post-marketing adverse event reporting for drugs, biologics, medical devices, combination products, and dietary supplements during a pandemic. FDA anticipates that during a pandemic,
Ennov PV – An Auto-Testing Revolution
[Reading time 5 minutes] Acceptance testing has always been an important part of our lives at Ennov PV. Understandably, our customers have high expectations with respect to quality in the products that we deliver. Pharmacovigilance
EudraVigilance Update, GVP Module IX, and the Impact on Signal Detection
With the release of the new Eudravigilance system on 22nd November 2017, the European Medicines Agency (EMA) have introduced greater access to adverse event data stored in the central repository. Furthermore, on the same day
Our Journey with Scrum
[Reading time 10-15 minutes] As we approach our first eighteen months of using the Agile Scrum methodology at Ennov PV, it seems a good time to reflect on our journey so far. It’s pretty obvious
Accelerating Drug Development: Unpacking FDA’s Master Protocol Guidance
In December, FDA issued a draft guidance, Master Protocols for Drug and Biological Product Development. This guidance is currently in the public comment period; comments received to date can be viewed on its Dockets page.
Navigating Certified Copies: A Global Guide to FDA, EMA, and Beyond
The clinical trial industry is constantly evolving, with electronic Trial Master Files (eTMF) becoming increasingly popular among sponsors and CROs. By reducing the need for paper documents and streamlining processes, eTMFs can help save time,
How Mobile EDC is Transforming Clinical Trials in 2023
Electronic Data Capture (EDC) has become an essential part of clinical trials, providing a more efficient way to collect, manage and analyze data. Mobile EDC applications, which can be run on tablets or mobile devices,
TMF Completeness: From Chaos to Order
TMF completeness findings are the most commonly reported inspection findings. For example, in them most recently published MHRA GCP inspection report , there were twice as many findings in this category than in the next
5 Myths About eTMF
Managing eTMF (electronic trial master file) is a challenge. However, some organizations impose burdens upon themselves by following practices that aren’t consistent with Health Authority guidance. In this blog article, I look at common misconceptions and provide
The Journey to Risk-Based Clinical Analytics
Read the White Paper: Clinical Analytics: The Journey from Problem Identification to Solution Encouraged by Health Authorities, Life Sciences organizations have moved towards risk-based approaches in almost all of their activities. To support a true
Archiving a CRO-Generated eTMF: Considerations for Sponsors
Summary Sponsors receiving TMFs from CRO partners at the end of a study often experience quality issues when attempting to archive the TMFs. This post provides recommendations for sponsors to help ensure that the TMF
MHRA Trial Master File (TMF) GCP Inspection Findings: Trends and Takeaways
On February 12, 2021, The UK Medicines & Healthcare Products Regulatory Agency (MHRA) published their annual GCP Inspections Metrics Report. This report covered the period from 1 April 2018 to 31 March 2019. For an
Clinical CAPAs: Are Your Trials in a State of Control?
The MHRA Inspectorate Blog recently posted a post [i] discussing Corrective and Preventive Actions, the importance of root cause analysis, and what triggers inspectors to believe that a quality system is not in a state
FDA Issues Final Guidance on Civil Money Penalties Relating to ClinicalTrials.gov
FDA has issued a final guidance document on Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank. This draft guidance was first issued in 2018 and has been revised with industry comments. Section 303(f)(3) of
Optimize Your eTMF Strategy
I have recently published a peer-reviewed paper called “Optimize Your eTMF Strategy”, that you can read or download on the Journal for Clinical Studies (Volume 11, Issue 11). I wanted to give you in this
6 Considerations for Selecting an EDC Solution
Electronic Data Capture (EDC) solutions have been used for a couple of decades now with more systems available today than one can count. From the big, well-known EDC providers, to the small not so well
New MoCRA Adverse Event Reporting Requirements: Impact on the Cosmetic Industry
Product safety and consumer protection stand at the forefront of the cosmetics industry, underpinned by regulatory frameworks like the Modernization of Cosmetics Regulation Act of 2022 and its 2023 amendment. These mandates highlight the growing
Why Unified Platforms are the Future of Cosmetovigilance
In an industry where innovation meets stringent safety requirements, cosmetovigilance (CV) stands as the critical backbone of consumer protection and brand integrity. The enactment of the EU Cosmetics Regulation 1223/2009 has brought about a renewed focus on
Dermatological Safety Assurance with Unified Platforms
The Challenge In the pursuit of dermatological excellence, maintaining the integrity of safety data is not merely an option; it is the bedrock of consumer trust. Companies bear the critical responsibility of overseeing product safety,
The Trust Equation: Safety, Branding, and Consumer Loyalty
In ethical skincare, the challenge is balancing safety, brand values, and consumer loyalty. Companies must align products with values, meet global safety standards, and navigate complexity during innovation and expansion. Consistent regulatory compliance and consumer
Holistic Beauty and Safety Compliance: Bridging the Gap
In holistic skincare, marrying natural wellness with global safety standards is challenging. Companies must ensure products are effective and safe while complying with diverse regulations in expanding markets. This balance is vital for brand integrity
Sustainability in Safety: The Cosmetovigilance Approach
In the organic skincare sector, balancing safety and sustainability is a challenge. Companies must meet strict safety standards while innovating eco-friendly products and navigating global regulations. Managing safety data sustainably, maintaining transparency, and building trust
Streamlining Operations with Digital Cosmetovigilance
In dermatology and aesthetic medicine, operational efficiency is vital. Companies must manage safety data efficiently, uphold product safety, and streamline operations to innovate faster while meeting global safety regulations. Scaling globally intensifies this challenge.
Strategic Safety Data Management for Cosmetic Compliance
The cosmetics industry is constantly changing, making safety data management a unique challenge. To adhere to global regulations, cosmetic companies need a versatile Cosmetovigilance (CV) system that evolves with the market. Choosing the right CV partner goes
Regulatory Compliance in the Cosmetics Industry
The cosmetics industry is subject to a complex array of regulatory frameworks that vary significantly across regions. In North America, for example, the FDA governs cosmetics under the Federal Food, Drug, and Cosmetic Act, which
Authors
Sean Carpenter
Regulatory Expert
Sean has over 20 years of experience in delivering Regulatory and Pharmaceutical Record Management solutions for a wide array of large and small Life Science companies.
He has experience as a consultant, product owner, business analyst and director of IT for software and services companies, from small start-ups to global multi-national organisations.
Josh Keliher
Solutions Expert
Josh Keliher has more than 20 years of experience as an expert in Life Science Regulatory, Quality and Clinical (eTMF, CTMS) IT solutions. He has worked for renowned Software Vendors and is currently a senior presales consultant at Ennov.
Alice Merrill
Regulatory Information Management Expert
Alice has worked in Regulatory Operations for 8 years, with expertise in Regulatory Information Management, process design and documentation and user support. As a RIM consultant, Alice brings her experience working in large pharmaceutical companies to supporting clients using Ennov InSight/RIM, developing best practices and ensuring that clients are up to date on all the latest regulatory developments.
Diarmuid Waide
Regulatory Information Management Expert
Diarmuid has 6 years of experience with Regulatory Publishing and RIM, managing submissions and submitting to agencies worldwide. Having published for large and small pharmaceutical companies he has a unique insight into both the working practices and needs each require. As a Senior Consultant with Ennov, Diarmuid will liase with clients regularly informing them of upcoming changes in the regulatory landscape and provide guidance on how to best use Ennov InSight/RIM to optimise their experience.
Nic Pillinger
Pharmacovigilance Expert
Nic has 18 years of experience with pharmacovigilance systems, in the UK and the USA, managing the product range and working with customers to implement and improve operations.
As the director of pharmacovigilance products, he ensures that Ennov’s pharmacovigilance offer meets the highest international standards.
Chet Shemanski
Marketing VP
Chet Shemanski is a proven business and information technology professional with extensive experience serving the healthcare and global life sciences industries.
He has specific expertise in software product commercialization including product management, product marketing, solution strategy, and alliance management.
Chet is a subject matter expert in eClinical and eRegulatory technologies, the author of industry journal articles and a speaker at industry conferences.
Steve Clark
Regulatory Expert
Steve has a Master’s Degree in Immunology from the University of Essex, UK and over 25 years of experience serving in various senior Regulatory Affairs and Regulatory Operations roles for companies including Gilead, Amgen, Merck, Baxter and Parexel.
He is responsible for the implementation of Ennov Regulatory systems and assisting the development of the Ennov Regulatory product suite.
