Managing Post-Approval CMC Changes with RIM & QMS
Perhaps no aspect of Regulatory Information Management (RIM) is more complicated than CMC changes. The published RIM Framework Interim Consensus Paper identifies CMC as a
Managing Post-Approval CMC Changes with RIM & QMS
Perhaps no aspect of Regulatory Information Management (RIM) is more complicated than CMC changes. The published RIM Framework Interim Consensus Paper identifies CMC as a
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
Health Canada News Roundup for Reg Affairs-Reg Ops
This year, Health Canada has issued a number of guidance documents (both draft and final) of interest to Reg Affairs and Reg Ops. In this
IDMP and RIM: Perfect Together?
Over the last five years or so, Health Authorities have laid the framework for the collection of structured data, rather than just documents, to identify
RIM Analytics: Dashboards with a Purpose
Effective Regulatory Information Management involves a constant stream of prioritizations, decision-making, and activity management and monitoring. Effective management occurs when prioritization is risk-based, decisions are
FDA News Roundup for Reg Affairs-Reg Ops
In the past six months, the FDA has issued a number of guidance documents (both draft and final) of interested to Reg Affairs and Reg Ops.
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
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
4 Ways to Reduce Regulatory Risk Using RIM
If you asked a regulatory colleague about the purpose of a Regulatory Information Management System (RIMS), they might say to provide replacement for spreadsheets, consolidate
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
Summary of Updates: Version 2.1 of the EMA IDMP Implementation Guide
With the ever-changing landscape of RIM system compliance, it’s crucial to remain up to speed with the latest guidelines. In this article, discover the changes
Interview with Regulatory Expert Steve Clark: Asphalion’s RegTalks RIM Series, Part III
Asphalion, a Scientific and Regulatory Affairs consultancy, hosts a weekly “RegTalk RIMS series”, one-to-one talks carried out by RIMS experts, aimed at informing about the
Interview with Regulatory Expert Steve Clark: Asphalion’s RegTalks RIM Series, Part II
Asphalion, a Scientific and Regulatory Affairs consultancy, hosts a weekly “RegTalk RIMS series”, one-to-one talks carried out by RIMS experts, aimed at informing about the
Interview with Regulatory Expert Steve Clark: Asphalion’s RegTalks RIM Series, Part I
Asphalion, a Scientific and Regulatory Affairs consultancy, hosts a weekly “RegTalk RIMS series”, one-to-one talks carried out by RIMS experts, aimed at informing about the
FDA eCTD-Related News
At Ennov’s recent Regulatory User Group meeting, my colleague Steve Clark provided an update on regulatory news covering the last six months. Our users appreciated
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
Brexit Lingers on in the RIM World
“A transition period, during which EU pharmaceutical law as laid out in the ‘Acquis Communautaire’ continued to be applicable to the UK, has ended on 31 December 2020.”
FDA News: FDA Updates Various eCTD Documents
Recently, the FDA updated a number of documents related to eCTD. These changes are summarized in the eCTD Submission Standards document, which provides a consolidated
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
FDA Removes Two-Way Communication from eCTD 4.0
FDA recently issued updates to their Electronic Common Technical Document (eCTD) v4.0 Technical Conformance Guide; FDA eCTD v4.0 Module 1 Implementation Package. The package was
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,
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
Preparing for IDMP: Insights from the Gens & Associates survey
Recently, I reviewed the results of the Gens & Associates’ World Class RIM Survey. There is a wealth of great information on RIM investments, benefits, practices,
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
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
Hosting GCP Inspections: Six interesting takeaways from the MHRA’s Blog Post
Recently, the MHRA published a detailed blog post on GCP Inspections: Expectations and the dos and don’ts for hosting. This post includes a lot 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
FDA Eliminates the need for Paper Device Submissions
Recently, the FDA issued a final rule to amend regulations on medical device premarket submissions to remove requirements for paper and multiple copies. Instead, sponsors will
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
Answering Complex Questions with RIM: Helping Sponsors Manage Divestitures
Most people think of Regulatory Information Management (RIM) as a set of tools and processes to manage product submissions and registrations, track regulatory commitments, and
Risk-Based Monitoring Improved
On July 17th, the FDA and Duke Margolis Center for Health Policy sponsored a workshop entitled “Improving the Implementation of Risk-Based Monitoring Approaches of Clinical
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
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
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
Top 5 eTMF Features | etmf systems
Managing essential documentation for clinical trials has become quite complex in today’s clinical research environment. Study sponsors are required to implement a quality system to
Realizing the Benefits of Mobile EDC
Most every clinical trial today is utilizing some form of Electronic Data Capture (EDC). An EDC system allows for easier data collection, data checking and
Managing Post-Approval CMC Changes with RIM & QMS
Perhaps no aspect of Regulatory Information Management (RIM) is more complicated than CMC changes. The published RIM Framework Interim Consensus Paper identifies CMC as a
Health Canada News Roundup for Reg Affairs-Reg Ops
This year, Health Canada has issued a number of guidance documents (both draft and final) of interest to Reg Affairs and Reg Ops. In this
IDMP and RIM: Perfect Together?
Over the last five years or so, Health Authorities have laid the framework for the collection of structured data, rather than just documents, to identify
RIM Analytics: Dashboards with a Purpose
Effective Regulatory Information Management involves a constant stream of prioritizations, decision-making, and activity management and monitoring. Effective management occurs when prioritization is risk-based, decisions are
FDA News Roundup for Reg Affairs-Reg Ops
In the past six months, the FDA has issued a number of guidance documents (both draft and final) of interested to Reg Affairs and Reg Ops.
4 Ways to Reduce Regulatory Risk Using RIM
If you asked a regulatory colleague about the purpose of a Regulatory Information Management System (RIMS), they might say to provide replacement for spreadsheets, consolidate
Summary of Updates: Version 2.1 of the EMA IDMP Implementation Guide
With the ever-changing landscape of RIM system compliance, it’s crucial to remain up to speed with the latest guidelines. In this article, discover the changes
Interview with Regulatory Expert Steve Clark: Asphalion’s RegTalks RIM Series, Part III
Asphalion, a Scientific and Regulatory Affairs consultancy, hosts a weekly “RegTalk RIMS series”, one-to-one talks carried out by RIMS experts, aimed at informing about the
Interview with Regulatory Expert Steve Clark: Asphalion’s RegTalks RIM Series, Part II
Asphalion, a Scientific and Regulatory Affairs consultancy, hosts a weekly “RegTalk RIMS series”, one-to-one talks carried out by RIMS experts, aimed at informing about the
Interview with Regulatory Expert Steve Clark: Asphalion’s RegTalks RIM Series, Part I
Asphalion, a Scientific and Regulatory Affairs consultancy, hosts a weekly “RegTalk RIMS series”, one-to-one talks carried out by RIMS experts, aimed at informing about the
FDA eCTD-Related News
At Ennov’s recent Regulatory User Group meeting, my colleague Steve Clark provided an update on regulatory news covering the last six months. Our users appreciated
Brexit Lingers on in the RIM World
“A transition period, during which EU pharmaceutical law as laid out in the ‘Acquis Communautaire’ continued to be applicable to the UK, has ended on 31 December 2020.”
FDA News: FDA Updates Various eCTD Documents
Recently, the FDA updated a number of documents related to eCTD. These changes are summarized in the eCTD Submission Standards document, which provides a consolidated
FDA Removes Two-Way Communication from eCTD 4.0
FDA recently issued updates to their Electronic Common Technical Document (eCTD) v4.0 Technical Conformance Guide; FDA eCTD v4.0 Module 1 Implementation Package. The package was
Preparing for IDMP: Insights from the Gens & Associates survey
Recently, I reviewed the results of the Gens & Associates’ World Class RIM Survey. There is a wealth of great information on RIM investments, benefits, practices,
FDA Eliminates the need for Paper Device Submissions
Recently, the FDA issued a final rule to amend regulations on medical device premarket submissions to remove requirements for paper and multiple copies. Instead, sponsors will
Answering Complex Questions with RIM: Helping Sponsors Manage Divestitures
Most people think of Regulatory Information Management (RIM) as a set of tools and processes to manage product submissions and registrations, track regulatory commitments, and
Hosting GCP Inspections: Six interesting takeaways from the MHRA’s Blog Post
Recently, the MHRA published a detailed blog post on GCP Inspections: Expectations and the dos and don’ts for hosting. This post includes a lot of
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
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,
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
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
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
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
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
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
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
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
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
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
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
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
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
Risk-Based Monitoring Improved
On July 17th, the FDA and Duke Margolis Center for Health Policy sponsored a workshop entitled “Improving the Implementation of Risk-Based Monitoring Approaches of Clinical
Top 5 eTMF Features | etmf systems
Managing essential documentation for clinical trials has become quite complex in today’s clinical research environment. Study sponsors are required to implement a quality system to
Realizing the Benefits of Mobile EDC
Most every clinical trial today is utilizing some form of Electronic Data Capture (EDC). An EDC system allows for easier data collection, data checking and
Authors
Kathie Clark
Clinical expert
Kathie is an expert in content management for the pharmaceutical industry, with over 20 years of experience implementing enterprise-level, validated solutions for major life sciences companies in the US, Europe, Japan and Israel.
In her prior positions, Kathie was responsible for the design and development of a number of document management products.
She is the author of many white papers and blog postings and is a regular presenter at industry conferences. Kathie is also a member of the DIA TMF Reference Model steering committee.
kclark@ennov.com
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
Regulatory 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.
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.