The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Bluefish Pharmaceuticals.
The aim of Safety reports is describe the safety during the lifecycle of the medicinal product. These reports are necessary during development as well as during the authorization process or renewal. In addition, several of these reports may be required by Health Authorities in case of safety concerns.
This presentation contains a full overview about periodic safety update reports and all the information related with it.
Introduction to Aggregate Reporting in Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
“Regulatory writing department at Turacoz have the expertise to develop various regulatory documents such as Investigator Brochures (IBs), Protocols, Clinical Study Reports (CSRs), Common Technical Documents (CTDs) and pharmacovigilance documents such as Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs). In these slides, we have presented an overview on Periodic safety update reports (PSURs) and also the guidelines such GVP modules and ICH E2c. We have also discussed the changes from old PSUR format to new Periodic Benefit-Risk Evaluation Report (PBRER) format.”
Development safety update report (dsur) pharmacovigilance and safetyAzierta
According to ICH guideline E2F (Step 5) on Development Safety Update Reports (DSURs) already implemented since 2011, companies must submit DSURs on a yearly basis for medicinal products involved in clinical trials. The focus of the DSUR is on data and findings from clinical trials of drugs and biologicals, whether they are authorized or not.
DSURs are internationally-harmonized, safety documents covering the safety summary of medicinal products during their development or clinical trial phase.
They are based heavily on the PSUR format already used for updating the safety record of drugs in their marketing phase.
A DSUR should be prepared after the first authorization of a clinical trial worldwide. A copy of the DSUR should be submitted to each concerned European Member State (MS) if a clinical trial is authorized in this MS for this investigational drug (still using the DIBD). Therefore, the first DSUR can be submitted to a concerned MS earlier than 1 year, but the covered reporting period should not be longer than 1 year.
The DSUR presents an annual review & evaluation of safety information:
• Information reported during the current review period and analysis based on previous knowledge of the products’ safety
• Description of new issues that may impact the overall program or specific clinical trials.
• Summarization of current understanding and management of known and potential safety risks to exposed patients.
• Provide an update on the status of the clinical development program.
In Azierta, scientific and healthcare consulting, we are experts in Pharmacovigilance and we have a team of highly qualified drug safety experts who support our clients to manage pharmacovigilance in an optimal way. Our work covers all areas of pharmacovigilance, both at the level of medicines, as well as medical devices and cosmetic products.
If you are interested in the contents of the good practices of pharmacovigilance (GVPs), as well as in other products related to pharmacovigilance visit our safety reports website for more details and feel free to contact us, we will be pleased to help you.
The aim of Safety reports is describe the safety during the lifecycle of the medicinal product. These reports are necessary during development as well as during the authorization process or renewal. In addition, several of these reports may be required by Health Authorities in case of safety concerns.
This presentation contains a full overview about periodic safety update reports and all the information related with it.
Introduction to Aggregate Reporting in Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
“Regulatory writing department at Turacoz have the expertise to develop various regulatory documents such as Investigator Brochures (IBs), Protocols, Clinical Study Reports (CSRs), Common Technical Documents (CTDs) and pharmacovigilance documents such as Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs). In these slides, we have presented an overview on Periodic safety update reports (PSURs) and also the guidelines such GVP modules and ICH E2c. We have also discussed the changes from old PSUR format to new Periodic Benefit-Risk Evaluation Report (PBRER) format.”
Development safety update report (dsur) pharmacovigilance and safetyAzierta
According to ICH guideline E2F (Step 5) on Development Safety Update Reports (DSURs) already implemented since 2011, companies must submit DSURs on a yearly basis for medicinal products involved in clinical trials. The focus of the DSUR is on data and findings from clinical trials of drugs and biologicals, whether they are authorized or not.
DSURs are internationally-harmonized, safety documents covering the safety summary of medicinal products during their development or clinical trial phase.
They are based heavily on the PSUR format already used for updating the safety record of drugs in their marketing phase.
A DSUR should be prepared after the first authorization of a clinical trial worldwide. A copy of the DSUR should be submitted to each concerned European Member State (MS) if a clinical trial is authorized in this MS for this investigational drug (still using the DIBD). Therefore, the first DSUR can be submitted to a concerned MS earlier than 1 year, but the covered reporting period should not be longer than 1 year.
The DSUR presents an annual review & evaluation of safety information:
• Information reported during the current review period and analysis based on previous knowledge of the products’ safety
• Description of new issues that may impact the overall program or specific clinical trials.
• Summarization of current understanding and management of known and potential safety risks to exposed patients.
• Provide an update on the status of the clinical development program.
In Azierta, scientific and healthcare consulting, we are experts in Pharmacovigilance and we have a team of highly qualified drug safety experts who support our clients to manage pharmacovigilance in an optimal way. Our work covers all areas of pharmacovigilance, both at the level of medicines, as well as medical devices and cosmetic products.
If you are interested in the contents of the good practices of pharmacovigilance (GVPs), as well as in other products related to pharmacovigilance visit our safety reports website for more details and feel free to contact us, we will be pleased to help you.
Safety reports rmp risk management plan pharmacovigilanceAzierta
A Risk management plan is a document based on safety profile of medicines that collects all pharmacovigilance activities and it is used to plan and implement measures in order to minimize risks.
This summary explains how to develop a Risk Management Plan according to European regulatory requirements.
Implementation dates and objectives of RMP module V of Good Pharmacovigilance Practices.
Literature Surveillance in Pharmacovigilance; Current Trends, Methods and Challenges
Please join Elizabeth E. Garrard, PharmD, founder and CEO of Garrard Safety Solutions, as she reviews key issues in literature surveillance for Pharmacovigilance.
Objectives:
• Understand the regulatory obligations, best sources and procedures for conducting literature surveillance.
• Appreciate some examples of when a safety signal was detected in the literature and its impact on the lifecycle of a drug.
• Understand when to start and where to look for emerging safety information.
• Setting up your search strategy, how to ensure your search strings are well balanced, recognizing the challenges between precision and sensitivity.
• What is the impact of the new literature monitoring by EMA of a number of substances in selected medical literature to identify suspected adverse reactions with medicines authorized in the European Union. Early insights into successes and issues.
• Discuss current methods that can increase the likelihood of early detection of a safety issue and minimize the issues surrounding.
• Realize the challenges we face including wide differences in quality, accuracy, and completeness in the scientific literature and how best to navigate these differences and maintain proper vigilance.
Importance of aggregate reporting in pharmacovigilanceSollers College
Pharmacovigilance is the science which deals with the activities related to the detection, assessment, understanding, and prevention of ADRs. The scope of Pharmacovigilance has evolved.
La gestión de riesgos en farmacovigilancia es una actividad global para salvaguardar la salud de los pacientes. Se autoriza un medicamento sobre la base de los resultados de estudios preclínicos y clínicos. Estos estudios generalmente se llevan a cabo en un pequeño número de pacientes en entornos controlados, por ejemplo, edad restringida, comorbilidad, comedicación y excluyendo poblaciones especiales como la población de edad avanzada, niños, mujeres embarazadas y lactantes. En el momento de la autorización, el riesgo-beneficio se considera positivo.
Sin embargo, no todos los riesgos reales o potenciales han sido identificados en el momento de la autorización. La gestión de riesgos es un conjunto de actividades realizadas para la identificación de riesgos, la evaluación de riesgos, la minimización o prevención de riesgos y la comunicación de riesgos. El Plan de gestión de riesgos (RMP) se desarrolla de acuerdo con las regulaciones y pautas aplicables. Sin embargo, en ausencia de pautas para un país, el plan se prepara de acuerdo con la guía ICH E2E sobre planificación de farmacovigilancia.
This presentation gives a brief knowledge of CIOMS, its history, missions and collaborations of CIOMS. This presentation also contains CIOMS organizational structure, detailed knowledge of CIOMS Former and Present Working Groups. This will also guide about CIOMS form, its reporting and details to be filled while reporting an ADR.
After adoption and success of E2B R2 for almost a decade finally change was brought to tear down and bring some more updates to the existing ICSR Elements Design.
Introduction to ICSR Workflow and Management in Drug Safety & Pharmacovigilance of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
PHARMACOVIGILANCE
The World Health Organization (WHO) defines Pharmacovigilance as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.”
ADVERSE DRUG REACTION
According to WHO “ADR is a response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function.”
Introduction to Expectedness/Unexpectedness Assessment in Drug Safety & Pharmacovigilance of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Safety reports rmp risk management plan pharmacovigilanceAzierta
A Risk management plan is a document based on safety profile of medicines that collects all pharmacovigilance activities and it is used to plan and implement measures in order to minimize risks.
This summary explains how to develop a Risk Management Plan according to European regulatory requirements.
Implementation dates and objectives of RMP module V of Good Pharmacovigilance Practices.
Literature Surveillance in Pharmacovigilance; Current Trends, Methods and Challenges
Please join Elizabeth E. Garrard, PharmD, founder and CEO of Garrard Safety Solutions, as she reviews key issues in literature surveillance for Pharmacovigilance.
Objectives:
• Understand the regulatory obligations, best sources and procedures for conducting literature surveillance.
• Appreciate some examples of when a safety signal was detected in the literature and its impact on the lifecycle of a drug.
• Understand when to start and where to look for emerging safety information.
• Setting up your search strategy, how to ensure your search strings are well balanced, recognizing the challenges between precision and sensitivity.
• What is the impact of the new literature monitoring by EMA of a number of substances in selected medical literature to identify suspected adverse reactions with medicines authorized in the European Union. Early insights into successes and issues.
• Discuss current methods that can increase the likelihood of early detection of a safety issue and minimize the issues surrounding.
• Realize the challenges we face including wide differences in quality, accuracy, and completeness in the scientific literature and how best to navigate these differences and maintain proper vigilance.
Importance of aggregate reporting in pharmacovigilanceSollers College
Pharmacovigilance is the science which deals with the activities related to the detection, assessment, understanding, and prevention of ADRs. The scope of Pharmacovigilance has evolved.
La gestión de riesgos en farmacovigilancia es una actividad global para salvaguardar la salud de los pacientes. Se autoriza un medicamento sobre la base de los resultados de estudios preclínicos y clínicos. Estos estudios generalmente se llevan a cabo en un pequeño número de pacientes en entornos controlados, por ejemplo, edad restringida, comorbilidad, comedicación y excluyendo poblaciones especiales como la población de edad avanzada, niños, mujeres embarazadas y lactantes. En el momento de la autorización, el riesgo-beneficio se considera positivo.
Sin embargo, no todos los riesgos reales o potenciales han sido identificados en el momento de la autorización. La gestión de riesgos es un conjunto de actividades realizadas para la identificación de riesgos, la evaluación de riesgos, la minimización o prevención de riesgos y la comunicación de riesgos. El Plan de gestión de riesgos (RMP) se desarrolla de acuerdo con las regulaciones y pautas aplicables. Sin embargo, en ausencia de pautas para un país, el plan se prepara de acuerdo con la guía ICH E2E sobre planificación de farmacovigilancia.
This presentation gives a brief knowledge of CIOMS, its history, missions and collaborations of CIOMS. This presentation also contains CIOMS organizational structure, detailed knowledge of CIOMS Former and Present Working Groups. This will also guide about CIOMS form, its reporting and details to be filled while reporting an ADR.
After adoption and success of E2B R2 for almost a decade finally change was brought to tear down and bring some more updates to the existing ICSR Elements Design.
Introduction to ICSR Workflow and Management in Drug Safety & Pharmacovigilance of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
PHARMACOVIGILANCE
The World Health Organization (WHO) defines Pharmacovigilance as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.”
ADVERSE DRUG REACTION
According to WHO “ADR is a response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function.”
Introduction to Expectedness/Unexpectedness Assessment in Drug Safety & Pharmacovigilance of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Presentation: Spotlight on prescription medicine post-market reformsTGA Australia
An overview of reform initiatives relevant to prescription medicines pharmacovigilance arising from the Review of Medicines and Medical Devices Regulation.
What you need to know about the Pharmacovigilance guidelines for companies marketing drugs in India. A concise overview of the six modules in the Guidance Document and the responsibilities of the Marketing Authorization Holders.
To recap the previous month's pharma highlights to Pharma Uptoday members, Monthly magazine Volume 6 has been released with
News Uptoday
New Guidance
New MAPP Release
Audit Findings
483 Observations
- 483 of Impax Laboratories
- 483 of Ipca Labs
- 483 of Bausch & Lomb Inc
- 483 of Alexion
Warning Letters
- Marck Biosciences Ltd.
- The Compounding Shop Inc.
- Zions Rx Formulations Services LLC.
EMA Non-Compliance Reports
- Renown Pharmaceuticals Pvt. Ltd., India
- VETPROM AD, Bulgaria
- SCM PHARMA LIMITED, UK
Guest of the Month
Dr. M Damodharan - Vice President Global Quality & Regulatory
Regulations of the Month
§ 211.180 Subpart J--Records and Reports - General Requirements
§ 211.182 Subpart J--Records and Reports - Equipment cleaning & use log
Building a link between ectd and xevmpdQdossier B.V.
Describing the role of XEVMPD/ IDMP in context of the regulatory environment and explaining the link with information managed within the eCTD and under GMP.
International Pharmaceutical Industry: Innovations in the PASS ConceptKCR
Read Magdalena Matusiak, KCR’s Pharmacovigilance Team Lead, review about the present regulatory and scientific approach to PAS studies. The article on innovations in the PASS concept has been published in the summer edition of International Pharmaceutical Industry magazine (p.28-31).
Turacoz Healthcare Solutions - Risk management plan is one of the many documents that come under regulatory writing. It is meant to be submitted to the health authorities during the process of gaining market authorization or at the time of any safety updates to the medicinal product.
Pharmacovigilance planning refers to the systematic and proactive approach taken by pharmaceutical companies, regulatory agencies, and other stakeholders to establish strategies and procedures for monitoring the safety of drugs throughout their lifecycle. It involves creating a comprehensive framework to detect, assess, understand, and prevent adverse effects or any other drug-related problems. Here are some key aspects to consider in pharmacovigilance planning
New PDA/IPEC Technical Report on Excipient Risk Assessment - insights for dru...MilliporeSigma
Access the interactive recording: https://bit.ly/37HqbTK
Abstract:
Since March 2016 the EU Guideline to ascertain the appropriate GMP for pharmaceutical excipients is legally binding. Although the EU Guideline itself provides a high level description how to perform the risk assessment, the implementation can be challenging. In January 2018 PDA and IPEC formed a joint Task Force with the objective to develop a joint Technical Report to share best practices with industry. This Technical Report was published in December 2019. In this webinar you will be introduced to the new Technical Report, its objective, proposed approaches and examples shared by PDA/IPEC member companies.
Similar to General principles of Periodic Safety Update Reports(PSUR)Psur by Julia Appelskog (20)
Medicines Verification Systems in Europe – a perspective from wholesale distr...László Árvai
The Falsified Medicines Directive and its Delegated Regulation on Safety Features
European Medicines Verification Organisation (EMVO) and the roll-out of National Medicines Verification Systems
GIRP and wholesale distributors perspectives on medicines verification systems
Impact on the actors in the supply chain
Best Practices in the Field of Serialization and Safe Supply Chain László Árvai
GS1 – and global standards • ABC – Argentina, Brasil, China and other countries – what is the world doing beyond Europe? • Serialisation – how and when? • Visibility in the supply chain – reality or myth • Patient Safety and the “Level below the Each”
The transparency of securities financing transactions in the EULászló Árvai
Capital Markets Union (CMU)
•EU capital markets are global
•Considerable progress has been made
•But inefficiencies, legal barriers, insufficient competition remain.
•Markets need to work better for the economy, delivering growth and jobs.
Potential career path between profilesLászló Árvai
Architects
Business
Development
Governance
Group IT - job profiles
Infrastructure
IT Development
IT Operations (development)
IT Service
Management
Management
Project Management
Security
Staff
Test Management
Agenda
Danske Bank IT – A Global Workforce
Career Path project vision and overview
Job profile example
Presentation of speaker
Paradigm shifts of IT Competencies
CSDR Technical Standards and Technical AdviceLászló Árvai
Presentation to explain ESMA’s on-going involvement in the drafting of
the CSDR Level 2 requirements
Outline of ESMA’s role in the Level 2 process
Reference to main stakeholder feedback to the ESMA consultation
papers and the related ESMA responses
Questions
What affects interview
• Overconfidence!
• Biases
- First impressions
- Stereotypes
- Like me/I like you
- Halo/horns
• Poor planning for interview (lack of knowledge of role and/or criteria)
• Poor decision making
• Lack of interviewing skills (questioning, listening, note taking, evaluating)
Why could this presentation be relevant for you?
IF you have: - duplications in your organisation
-unclear processes
-unclear responsibilities Or: - It is not clearly defined, who your internal consumers are - What are the real added value activies? - You do not exactly know how measure the effectiveness?
CHALLENGES FOR A CRO IN A NEARLY GONE CONCERN OPERATING ENVIRONMENTLászló Árvai
Banca Marche is a very typical commercial retail bank, offering a wide range of products and services… … at the end of 2012 (last official figures available)… was among the first 20 Italian banks in terms of total assets (23 bln) had a very high market share in Marche Region (25%, 23% deposits and 20% branches) and about 1% of whole Italian market share (1,0% loans, 0,8% deposits and 1,0% branches)
Are CCPs here to manage risk or instead to cause it?
•Changing environment: security vs capital efficiency
•Diversity killed by regulation?
•CCP default scenario: recovery vs resolution
2
Credit Risk Losses | Real Losses Are they inconsistent?László Árvai
Focusing on:
• Contracting a new deal
• Good and properous customer relationship
• To have nice conversation
• Learn all the needs of his client
• Write a loan application
• Fill in the forms of the system
• Cope with all the compliance „handicaps“
• Analyse the business plan, the forecast, …
The post trade challenges of implementing CSDR settlement discipline: Mandato...László Árvai
What is a buy-in, and how do they work?
What is cash compensation?
The challenges of buy-ins and cash compensation
CSDR Level 1 and mandatory buy-ins
The Level 2 ESMA Consultation Paper: the 3 options for a buy-in mechanism
The challenges with the options
Conclusion (the need to amend the Level 1 text)
CSDR Mandatory Buy-ins
1 . How did we get into this mess
•Ukraine is one of only two countries of the FSU yet to recover to its 1991 level of GDP
–Total reform failure
–Got democracy but Yanukovych was a bad choice
•In the last decade Russia has been transformed into a “normal” country
(albeit with a lot of problems)
100 mln clients 6 countries 70,000 employees
TOP-3 best employers
85% vacancies are closed by internal candidates
TOP-10 best companies for leaders in Russia (2014)
G20 (2009): Strengthen loan loss accounting using broader
range of information aiming at greater stability
IFRS 9: 3S-approach replaces Incurred Loss (IL)-approach
Basel Committee Guidelines: Are claims justified?
higher model quality and backtesting
Macroeconomic projections
Denouncing shortcuts (e.g. 30d past due)
For lack of empirical evidence: Let’s use simulations
Revolving 10Y-loan portfolio, infinitely granular follows Moody’s
US-Corp. migration statistics, transfer S1/2: 3notch downgrade
(papers.ssrn.com/sol3/papers.cfm?abstract_id=2187515
Latino Buying Power - May 2024 Presentation for Latino CaucusDanay Escanaverino
Unlock the potential of Latino Buying Power with this in-depth SlideShare presentation. Explore how the Latino consumer market is transforming the American economy, driven by their significant buying power, entrepreneurial contributions, and growing influence across various sectors.
**Key Sections Covered:**
1. **Economic Impact:** Understand the profound economic impact of Latino consumers on the U.S. economy. Discover how their increasing purchasing power is fueling growth in key industries and contributing to national economic prosperity.
2. **Buying Power:** Dive into detailed analyses of Latino buying power, including its growth trends, key drivers, and projections for the future. Learn how this influential group’s spending habits are shaping market dynamics and creating opportunities for businesses.
3. **Entrepreneurial Contributions:** Explore the entrepreneurial spirit within the Latino community. Examine how Latino-owned businesses are thriving and contributing to job creation, innovation, and economic diversification.
4. **Workforce Statistics:** Gain insights into the role of Latino workers in the American labor market. Review statistics on employment rates, occupational distribution, and the economic contributions of Latino professionals across various industries.
5. **Media Consumption:** Understand the media consumption habits of Latino audiences. Discover their preferences for digital platforms, television, radio, and social media. Learn how these consumption patterns are influencing advertising strategies and media content.
6. **Education:** Examine the educational achievements and challenges within the Latino community. Review statistics on enrollment, graduation rates, and fields of study. Understand the implications of education on economic mobility and workforce readiness.
7. **Home Ownership:** Explore trends in Latino home ownership. Understand the factors driving home buying decisions, the challenges faced by Latino homeowners, and the impact of home ownership on community stability and economic growth.
This SlideShare provides valuable insights for marketers, business owners, policymakers, and anyone interested in the economic influence of the Latino community. By understanding the various facets of Latino buying power, you can effectively engage with this dynamic and growing market segment.
Equip yourself with the knowledge to leverage Latino buying power, tap into their entrepreneurial spirit, and connect with their unique cultural and consumer preferences. Drive your business success by embracing the economic potential of Latino consumers.
**Keywords:** Latino buying power, economic impact, entrepreneurial contributions, workforce statistics, media consumption, education, home ownership, Latino market, Hispanic buying power, Latino purchasing power.
how to sell pi coins effectively (from 50 - 100k pi)DOT TECH
Anywhere in the world, including Africa, America, and Europe, you can sell Pi Network Coins online and receive cash through online payment options.
Pi has not yet been launched on any exchange because we are currently using the confined Mainnet. The planned launch date for Pi is June 28, 2026.
Reselling to investors who want to hold until the mainnet launch in 2026 is currently the sole way to sell.
Consequently, right now. All you need to do is select the right pi network provider.
Who is a pi merchant?
An individual who buys coins from miners on the pi network and resells them to investors hoping to hang onto them until the mainnet is launched is known as a pi merchant.
debuts.
I'll provide you the Telegram username
@Pi_vendor_247
how can i use my minded pi coins I need some funds.DOT TECH
If you are interested in selling your pi coins, i have a verified pi merchant, who buys pi coins and resell them to exchanges looking forward to hold till mainnet launch.
Because the core team has announced that pi network will not be doing any pre-sale. The only way exchanges like huobi, bitmart and hotbit can get pi is by buying from miners.
Now a merchant stands in between these exchanges and the miners. As a link to make transactions smooth. Because right now in the enclosed mainnet you can't sell pi coins your self. You need the help of a merchant,
i will leave the telegram contact of my personal pi merchant below. 👇 I and my friends has traded more than 3000pi coins with him successfully.
@Pi_vendor_247
Turin Startup Ecosystem 2024 - Ricerca sulle Startup e il Sistema dell'Innov...Quotidiano Piemontese
Turin Startup Ecosystem 2024
Una ricerca de il Club degli Investitori, in collaborazione con ToTeM Torino Tech Map e con il supporto della ESCP Business School e di Growth Capital
what is the best method to sell pi coins in 2024DOT TECH
The best way to sell your pi coins safely is trading with an exchange..but since pi is not launched in any exchange, and second option is through a VERIFIED pi merchant.
Who is a pi merchant?
A pi merchant is someone who buys pi coins from miners and pioneers and resell them to Investors looking forward to hold massive amounts before mainnet launch in 2026.
I will leave the telegram contact of my personal pi merchant to trade pi coins with.
@Pi_vendor_247
The secret way to sell pi coins effortlessly.DOT TECH
Well as we all know pi isn't launched yet. But you can still sell your pi coins effortlessly because some whales in China are interested in holding massive pi coins. And they are willing to pay good money for it. If you are interested in selling I will leave a contact for you. Just telegram this number below. I sold about 3000 pi coins to him and he paid me immediately.
Telegram: @Pi_vendor_247
how to sell pi coins on Bitmart crypto exchangeDOT TECH
Yes. Pi network coins can be exchanged but not on bitmart exchange. Because pi network is still in the enclosed mainnet. The only way pioneers are able to trade pi coins is by reselling the pi coins to pi verified merchants.
A verified merchant is someone who buys pi network coins and resell it to exchanges looking forward to hold till mainnet launch.
I will leave the telegram contact of my personal pi merchant to trade with.
@Pi_vendor_247
Even tho Pi network is not listed on any exchange yet.
Buying/Selling or investing in pi network coins is highly possible through the help of vendors. You can buy from vendors[ buy directly from the pi network miners and resell it]. I will leave the telegram contact of my personal vendor.
@Pi_vendor_247
What price will pi network be listed on exchangesDOT TECH
The rate at which pi will be listed is practically unknown. But due to speculations surrounding it the predicted rate is tends to be from 30$ — 50$.
So if you are interested in selling your pi network coins at a high rate tho. Or you can't wait till the mainnet launch in 2026. You can easily trade your pi coins with a merchant.
A merchant is someone who buys pi coins from miners and resell them to Investors looking forward to hold massive quantities till mainnet launch.
I will leave the telegram contact of my personal pi vendor to trade with.
@Pi_vendor_247
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General principles of Periodic Safety Update Reports(PSUR)Psur by Julia Appelskog
1. General principles
of Periodic Safety
Update Reports
(PSUR)
2014-09-26
Dr. Julia Appelskog
EU QPPV
Head of Pharmacovigilance
Bluefish Pharmaceuticals
2014-09-26
2. 2 PUBLIC
Disclaimer
The views and opinions expressed in the following PowerPoint slides are
those of the individual presenter and should not be attributed to Bluefish
Pharmaceuticals.
These PowerPoint slides are the intellectual property of the individual
presenter and are protected under the copyright laws. Used by permission.
All rights reserved.
2014-09-26
3. 3 PUBLIC
Abbreviation
CAP Centrally Authorised Product
CHMP Committee for Medicinal Product for Human Use
CMDh Coordination Group for Mutual Recognition and Decentralised Procedures
– Human
DLP Data Lock Point
DCP Decentralised procedure
EMA European Medicines Agency
MA Marketing Authorisation
MAH Marketing authorisation holder
MA Member State
MRP MRP: Mutual Recognition procedure
NAP Nationally Authorised Product (in the frame of this presentation includes
also DCP/MRP)
PRAC Pharmacovigilance Risk Assessment Committee
PSUR Periodic Safety Update Report
2014-09-26
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Agenda
1 History of the PSUR
2 PSUR preparation
3 PSUR submission: Outcome of the
transitioning to the new system
4 PSUR Assessment
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Purpose of the Periodic Report
PSURs as benefit risk decision-making tool
The main purpose of PSUR is to present a comprehensive, concise, and
critical analysis of new or emerging information on the risks of the medicinal
product
To consider whether any action concerning the MA for the medicinal
product is necessary
Relates safety data to patient exposure
Consider changes to product information to optimise product use
2014-09-26
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1996
Step 4 – ICH E2C Guideline -
Clinical Safety Data Management
- Periodic Safety Update
Reports for Marketed Drugs
2003
Step 4 - Addendum to ICH
E2C (R1) published
2012
ICH guideline
E2C (R2) on periodic
benefit-risk evaluation
report (PBRER)
2012-2013
GVP Module VII –
PERIODIC SAFETY
UPDATE REPORT
1992
CIOMS II Guideline on PSURs
published
History of the PSUR
2014?
2014-09-26
7. 7 PUBLIC7
Spirit of the legislation
New legal requirements for PSURs:
Risk-based and proportionate approach
Central repository
PSUR single assessment: strengthens the Community system instead of
fragmented approaches on a national level
Extended preparation and submission deadlines
2014-09-26
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Relief for well-known products
Article 10(1)
Generic products
Article 10a
Well established
use products
Article 14
Homeopathic
medicines
Article 16
Traditional herbal
medicines
The legislation waives the obligation to
submit PSURs routinely (unless there is a
condition in the MA or requested by a CA):
2014-09-26
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Implementation
July 2012
- New format and content of PSUR + PRAC involvement in CAPs
1 April 2013
- EURD list binding => PSUSA procedure involving PRAC implemented
for CAPs and NAPs containing the same active substance or
combination of active substances
-
31st of August 2014
- Establishing of PSUR single assessment for NAP
2014-09-26
11. 11 PUBLIC
EURD list
EURD = EU reference date list for PSUR submissions
Harmonisation of DLP and frequency of PSUR submission for products
authorised in several Member States
Periodicity defined on a risk-based approach
Increase of predictability in terms of PSUR submission
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EURD list
Monthly updated by EMA (Updates published at end of each month with
changes highlighted in colour)
- Outcomes of procedures (e.g. referrals, safety variations, extension of
indication, renewal, PSUR assessments that result in change in DLP,
PSUR frequency)
- Authorisation of a new substance
- Harmonisation of DLP with IBD
The revised EURD List is adopted by the CHMP/CMDh after consultation of
the PRAC
Any change to the dates of submission and frequency takes effect 6 months
after the publication date
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PSUR Work Sharing
During the transition period until single assessment is established some
active substances for NAPs have been temporarily removed from the EURD
and have been included in the ‘List of Substances under PSUR Work
Sharing Scheme and Other Substances contained in Nationally Authorised
Products with DLP Synchronised’.
2014-09-26
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New PSUR services
Changes to EMA organisation announced 26
March 2014
Revised operations for PSURs
New roles:
- Procedure Manager (PM) - oversees all
aspects of the management of procedure
(main contact).
- Procedure assistant (PA)
- Specialised input from risk management
specialist, or regulatory affairs as needed.
Allocation of PM and PA well in advance of
submission
Pre-submission queries:
PSURquery@ema.europa.eu
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New PSUR
Structure
- PSUR structure defined by law and includes a scientific evaluation of the
benefit-risk balance
- Regulation 520/2012, GVP Module VII, ICH E2C(R2) provide the
guideline on the format and structure
- Line listings no longer required
Benefit evaluation
- Important efficacy-effectiveness information
- Newly identified efficacy-effectiveness information
Integrated benefit-risk analysis
- Importance of benefits and risks
- Discussion of the benefit-risk balance
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Format
Part I Title page including signature
Part II Executive Summary
Part III Table of contents
1. Introduction
2. Worldwide marketing authorisation status
3. Actions taken in the reporting interval for safety
reasons
4. Changes to reference safety information
5. Estimated exposure and use patterns
5.1. Cumulative subject exposure in clinical trials
5.2. Cumulative and interval patient exposure from
marketing experience
6. Data in summary tabulations
6.1. Reference information
6.2. Cumulative summary tabulations of serious adverse
events from clinical trials
6.3. Cumulative and interval summary tabulations from
post-marketing data sources
7. Summaries of significant findings from clinical trials
during the reporting interval
7.1. Completed clinical trials
7.2. Ongoing clinical trials
7.3. Long-term follow-up
7.4. Other therapeutic use of medicinal product
7.5. New safety data related to fixed combination
therapies
9. Information from other clinical trials and sources
10. Non-clinical data
11. Literature
12. Other periodic reports
13. Lack of efficacy in controlled clinical trials
14. Late-breaking information
15. Overview on signals: New, ongoing or closed
16. Signal and risk evaluation
16.1. Summaries of safety concerns
16.2. Signal evaluation
16.3. Evaluation of risks and new information
16.4. Characterisation of risks
16.5. Effectiveness of risk minimisation (if applicable)
17. Benefit evaluation
17.1. Important baseline efficacy and effectiveness
information
17.2. Newly identified information on efficacy and
effectiveness
17.3. Characterisation of benefits
18. Integrated benefit-risk analysis for authorised
indications
18.1. Benefit-risk context — Medical need and
important alternatives
18.2. Benefit-risk analysis evaluation
19. Conclusions and actions
20. Appendices to the periodic safety update report2014-09-26
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General principles
All relevant safety information
- non-clinical studies;
- clinical trials, including research in unapproved indications or populations;
- spontaneous reports (for example, on the MAH’s safety database);
- MAH-sponsored websites
- product usage data and drug utilization information;
- published scientific literature or reports from abstracts including information presented at
scientific meetings; unpublished manuscripts;
- observational studies such as registries; active surveillance systems; systematic reviews
and meta-analyses;
- information arising from licensing partners, other sponsors or academic
institutions/research networks; patient support programmes;
- investigations of product quality;
- information from regulatory authorities.
Worldwide market authorization status
- Should be by date so that the reader can follow the issues
(frequently ordered alphabetically by country)
Update on Regulatory or MAH actions taken for safety reasons
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General principles
One report for one active substance
- Separate section for data relating to particular indication, dosage form, route of
administration, dosing regimen, patient population (eg paediatric use)
Separate PSUR in exceptional cases
Fixed combination:
- Separate PSUR with cross reference to PSUR for each substance
Joint PSURs possible (>1 MAH)
Each MAH responsible for PSUR
- Companies must share information
- Specify in the Agreement who is responsible
In-Licensed products
- Either submit licensor's PSUR report OR
- Submit own (refer to licensors report or include licensor's data)
2014-09-26
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Industry experience
Multiple request from CA to present data in “old style” PSUR format
Requests to include full narratives and CIOMS I forms
Requests presentation of cases by listedness
Requests for more details on individual cases rather than summary
Inclusion of line listings of all fatal cases
Requests for different presentations of data:
- HCP and consumer reports by SOC;
- Data presented by source, seriousness, listedness, medically confirmed etc.
Clinical Trial Information
- Requests to use the PSUR as a tool to update recruitment status of studies.
- Requests to provide a complete overview of all CTs
Signals
- Requests for cumulative signal data in the Table in Section 15
2
0
2014-09-26
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Procedural Issues
Challenges with timelines
-6 month PSURs overlap with Preliminary AR from previous PSUR,
expectation of MAH to complete AR process and next PSUR at the same time
-Final PRAC assessment report is not always received in time to incorporate
the comments into the next PSUR
-Short timeframe (changes to SmPC required within short time frames).
MAH Engagement
-Perceived lack of EMA contact for questions within tight timeframes
-Lack of direct contact with PRAC Rapporteur for any clarifications required
-Limited Opportunity for MAH interaction - day 90, PAR only. Opportunity to
appeal a decision?
2
1
2014-09-26
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PSUR submission
According to the EU reference dates list
- The list overrules any PSUR requirements laid down in the MA
According to a condition of the MA or
According to Art 107c (2) of Directive 2001/83/EC and Art 28 (2) of
Regulation (EC) N. 726/2004:
- Every 6 months during the first 2 years
- One a year for the following 2 years
- Three-yearly intervals thereafter
PSURs also need to be submitted upon request from a CA
“If substance not in the list : follow the submission frequency as per condition
in the MA if any, otherwise, follow the standard submission schedule”
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Pre-submission phase
Extended pre-submission phase to prepare submission with MAHs.
Notification to be sent to MAHs identified as part of the PSUSA in advance
of the submission date (advice note will be sent ca. 2 month prior to
submission date)
Advice note will include information such as:
- Procedure number
- Submission deadline
- Lead PRAC Rapporteur
- Submission requirements
- Line listing of authorised products
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Pre-submission phase
Consolidation of submissions in the MS and/or Agency
- Experience shows that there is a need to consolidate submissions at
MS-level prior to start of PSUSA
After successful audit of PSUR repository, MAHs may still submit only to
MS for 12 more months
Introduction of a 10 working days delay between submission and start for
PSUSAs containing NAPs (for MS reconciliation)
Consolidated package will be made available to lead Rapporteur at start of
procedure
New terminology: “PSUSA cut-off date”.
2014-09-26
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To whom shall you submit PSUR?
CAPs
• PSURs to be submitted to:
• The EMA
• The Rapporteur appointed for
the procedure
• All other Committee Members
of the PRAC.
NAPs* involved in
a PSUSA
• PSURs to be submitted to:
• All Member States in which the
medicinal product has been
authorised
• The EMA
• The PRAC Rapporteur
appointed for the procedure.
Note: The term Nationally Authorised Product is intended to encompass medicines
authorised through MRP and DCP and purely nationally authorised products where
authorised in more than one Member State.
2014-09-26
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Requirements of the (Co-) Rapporteurs and other Committee members
http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guidelin
e/2009/10/WC500003980.pdf
2014-09-26
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Current situation
Different formats of PSUR submissions in the MS for NAPs:
- eCTD
- NeeS
- Paper
Different extent of use of CESP
PSUR within eCTD product lifecycle in most MS preferred
PSUR submissions mostly stored within product related repository
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Current situation
Submission requirements % NCA
Submissions through CESP can be used (optional) 58%
A signed copy of the cover letter should be provided in paper
together with the CD/DVD (wet signature)
55%
A copy of the cover letter should be provided in paper with the
CD/DVD (no wet signature needed)
26%
The eCTD or NeeS must include a scanned copy of the signed
Cover Letter
39%
Email/EudraLink is accepted instead of the CD/DVD
(Max 80 MB)
23%
National portal can be used (optional) - see NCA website. 3 % (UK)
National portal must be used - see NCA website. 3% (ES)
Electronic signatures are accepted 19%
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PSUR repository
Legal requirement for EMA to set up a PSUR repository (Article 25a of
Regulation (EC) 726/2004 as amended:
- The Agency shall, in collaboration with the national competent authorities and the
Commission, set up and maintain a repository for periodic safety update reports (hereinafter
the “repository”) and the corresponding assessment reports so that they are fully and
permanently accessible to the Commission, the national competent authorities, the PRAC,
the Committee for Medicinal Products for Human Use and the coordination group referred to
in Article 27 of Directive 2001/83/EC.
A common storage place for:
- PSUR
- PSUR assessment reports
- PRAC recommendations
Advantages:
- Centralised PSUR reporting
- Enhance access to data and information
- Fast benefit risk assessments of medicines.
PRAC Recommendations
PSUR PSUSA
MAH 1 MAH 2 MAH 3 MAH 4
CA 1 CA 2 CA 3 CA 4
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PSUR Repository
Legal References
Regulation (EC) 726/2004 as
amended
- Article 25a
- Article 28 paragraph 3
Directive 2001/83/EC as
amended
- Article 107b paragraph 2
- Article 107b paragraph 1
Requirements
Accessibility of documents
Allow search and queries
Possibility to export the information
Performances requirements (speed,
scalability)
Allows unique identification
Submission of documents
Allow validation and quality monitoring
Download functionality
Storage capacity requirements:
- To store and archive a significant amount of
documents and the different versions
- The number of individuals PSURs received
per year is estimated to be 10,000
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Documents to be stored in the repository
MAH cover letter
PSUR
Timetable for PSURs related procedure
PSURs Assessment Reports
Final assessment conclusions
Comments on PSURs Assessment Report
ICSRs Line Listing from the EudraVigilance Database
Summary Tabulations from the EudraVigilance Database
PRAC Recommendations following adoption of the Assessment Report
Coordination Group Position and detailed explanation on scientific grounds for the
differences to PRAC recommendations
1. CHMP opinion
2. Detailed explanation on scientific grounds for the differences to PRAC recommendations
Commission Decision
Update to the Product Information related to the procedure
List of Union Reference Dates and Frequencies of PSURs submission
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Access to the PSUR Repository
European Commission
National Competent Authorities
PRAC Members
CHMP Members
Coordination Group Members
EMA Secretariat
MAHs
- Restricted access to MAH will simplify the process. This capability will be considered
based on a cost-implication analysis. If access cannot be granted, the EMA will provide the
MAH with the relevant documents via alternative methods (e.g. email or web posting).
The General Public.
- Final assessment conclusions, recommendations, opinions and decisions will be made
publicly available by means of the European medicines web-portal. Technical links may
have to be established between the PSUR repository and the web-portal.
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Legal
requirement
Q1-Q2 2014
Definition of user
requirements
Q4 Pilot
phase with
MAHs
Available in
Q1 2015
PSUR Repository
PSUR Repository planned to be available in Q1 2015 and compulsory in 2016
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PSUR single assessment (PSUSA)
Started
in July
2012
CAPs
Started in
April 2013
(EURD list
entered into
force)
CAPs
+
NAPs
DLP
after 31st
August
2014
NAPs
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Assessment report
A unique version of the AR is sent to all MAHs that submitted as part of a
PSUSA.
The EMA is redacting the documents by deleting confidential commercial
information and patient personal data (PPD) in accordance with the criteria
described in the HMA/EMA document on handling requests for access to
PSURs applied (EMEA/743133/2009).
A disclaimer is included in the EURD list:
- “Single Assessment Reports of PSURs are shared among all Marketing
Authorisation Holders involved in the concerned procedure.”
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Recommendations on the handling of access to PSURs
EMEA/743133/2009. Access to PSURs has to be
only reactive and on request
The minimum personal data to be deleted to ensure
anonymisation of the information would require the
deletion of information on:
- Date of birth, (Reporting) country, Patient
identification code
“Commercially confidential information” is generally
considered to fall broadly into two categories:
- Confidential intellectual property, “know-how”,
and trade secrets (including e.g. formulas,
programs, process or information contained or
embodied in a product, unpublished aspects of
trade marks, patents, etc).
- Commercial confidences (e.g. structures and
development plans of a company).
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Timetable
Day Action
Day 0 Start of the procedure according to the published timetable
Day 60 PRAC Rapporteur’s / Member State preliminary assessment report
Day 90* MAH and PRAC members’ / Member States comments
Day 105 PRAC Rapporteur’s / Member State updated assessment report (if
necessary)
Day 120 PRAC recommendation adoption with the final PRAC assessment
report
Day 134 CHMP opinion / CMDh position (in case PRAC recommends a
variation, suspension or revocation of the MA)
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Day 90
The MAH is expected to provide, as applicable, by Day 90:
- responses to the “request for supplementary information” as outlined in the
relevant section of the PRAC Rapporteur / Member State PSUR preliminary
assessment report,
- comment on the proposed wording (in case the recommendation is a
variation),
- propose a wording in case the recommendation is a variation but no exact
wording is proposed by the PRAC Rapporteur / Member State,
- provide a justification in case the MAH does not agree with the PRAC
Rapporteur / Member State recommendation to vary, suspend or revoke the
MA; and/or
- include additional comments or clarification deemed necessary by the MAH.
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Deviation from Principles of EU Legislation and ICH E2C
Inconsistent requests and interpretation by Assessors
- Lack of clarity regarding how assessors review signals and conclude on the data
- Expectation that old style PSUR will be followed re reviews
- Wide range of difference in experience and quality of Assessment Reports
Lack of understanding of the Global Nature of the PSUR/ PBRER
- Global implications of changing the EURD date/impact on submission outside
the EU
- Specific indication requests for Europe – this results in multiple and duplicated
work when annual PSUR/PBRER is not accepted in place of a six monthly report
( deviation from international harmonisation principles)
- Question in an AR: “What does PBRER stand for?”
4
2
2014-09-26
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PSUR assessment
SCOPE
Strengthening Collaborations for
Operating Pharmacovigilance in
Europe http://www.scopejointaction.eu/
Delivering tools for regulators
- “best practice”,
recommendations, guidance
based on successful
implementations
- Training (such as for PSUR
assessment)
WP 8 – Lifecycle PV
1. Identification of available data
sources outside spontaneous
reporting – lead: AIFA
2. Risk Management Plan assessments
– lead: NOMA
3. Post Authorisation Safety (and
Efficacy) Studies protcols and study
reports – lead: MPA
4. Benefit/risk assessment in the context
of PSUR and referral procedures -
lead: AIFA
5. Competency – lead: AIFA
2014-09-26
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Regulatory actions following assessment report
Maintenance of the MA
Suspension of the MA
Revocation of the MA
Variation of the MA
- new contraindication
- restriction of the indication
- reduction of the recommended dose
- SmPC/PL update (mainly changes to section 4.4 and 4.8 of the SmPC)
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Maintenance of the MA
No change to Product Information/ Conditions of MA
Request for cumulative review
RMP update
Amendment of the EURD list:
- frequency of PSUR
- separate/single PSUR per indication, pharmaceutical form, fixed-dose
combination
Example from Jul 2014 PRAC meeting: Abatacept – ORENCIA
2014-09-26
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PSUR fee
REGULATION (EU) No 658/2014 OF THE EUROPEAN PARLIAMENT AND OF THE
COUNCIL of 15 May 2014 on fees payable to the European Medicines Agency for the
conduct of pharmacovigilance activities in respect of medicinal products for human use
From 26th of August 2014 the Agency charges procedure-based fees for the single assessment
of PSURs
- The fee for the assessment of PSUR is EUR 19 500 per procedure
For the PSUR assessment under a PSUSA procedure involving more than one MAH, the total
amount of the fee will be divided among all the MAHs concerned proportionately to the number
of chargeable units.
The MAH concerned will be established on the basis of the obligation to submit the PSUR(s)
and not on the basis of the actual PSUR submission(s) received by the EMA.
The total of chargeable units in the procedure will be identified from the Art. 57 database.
An advice note will be sent 3 months prior to the start date to the relevant QPPVs
The invoice will be sent to each MAH with the relevant chargeable units calculation. The fee will
be due to the EMA within 30 calendar days.
Reduced fee for an SME (i.e. micro-, small- or medium-sized enterprise) companies
2014-09-26
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Common inspection findings
Non-submission
- Complete non-submission of PSURs
- Submission the correct time frames
Poor quality reports
- Incorrect format of the document
- New safety signals not or poorly assessed
- Medication error not highlighted
- Absence of use of standardized medical terminology (e.g. MedDRA)
- Published literature is not properly reviewed
- No conclusion drawn
Omission of required information
- Update of Regulatory or MAH Actions taken for Safety Reasons
- Changes to Reference Safety Information
- Patient Exposure (poorly calculated, explanation of calculation is missing)
Previous requests from Competent Authorities not addressed (e.g. close
monitoring of specific safety issues)
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Conclusions
Where we are?
Still in learning phase
Gained experience with CAP and mixed
single assessments for CAPs and NAPs
- Harmonization and efficiency
- Rapid update of product information
- Areas for clarification
Room for improvement
Transparency
What is next?
PSUR single assessment for NAP (PSUSAs)
PSUR repository
Planned update of the PSUR template
2014-09-26