Safety Data Exchange Agreements (Brief)
An integral part of enterprise risk management systems
Strategic management framework
Governance model
Standards, mechanisms, and metrics for management oversight
Roles and responsibilities
Stakeholder collaboration
Procedural documents and SDEA templates
CAPA management processes
Supporting systems
Document repositories
“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.”
Safety Data Exchange Agreements (Brief)
An integral part of enterprise risk management systems
Strategic management framework
Governance model
Standards, mechanisms, and metrics for management oversight
Roles and responsibilities
Stakeholder collaboration
Procedural documents and SDEA templates
CAPA management processes
Supporting systems
Document repositories
“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.”
GVP stands for Good Pharmacovigilance Practices, which are a set of guidelines and regulatory requirements that provide a framework for the conduct of pharmacovigilance activities. The GVP modules outline specific areas of pharmacovigilance and provide detailed guidance on various aspects. Here are the main GVP modules
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.
Identifying Safety Signals by Data Mining the FDA Adverse Event Reporting Sys...Perficient, Inc.
Ever since the European Union (EU) introduced new legislation that requires life sciences companies to proactively detect, prioritize, and evaluate safety signals, there has been an increased interest, not only from sponsors and CROs in the EU, but globally, in pharmacovigilance systems that can assist with the signal management process.
Perficient's Chris Wocosky, an expert in signal detection and management, shows how your organization can use Empirica Signal, Oracle's state-of-the-art signal detection system to data mine the existing FDA Adverse Event Reporting System (FAERS) to determine safety signals. This presentation and demonstration willhelp you bettter understand how this solution can be used in daily pharmacovigilance activities.
This Module provides guidance on planning and conducting the legally required audits, the role, context and management of pharmacovigilance audit activity.
The principles in this module are aligned with internationally accepted auditing standards, issued by relevant international auditing standardization organizations and support a risk-based approach to pharmacovigilance audits.
Regulatory requirements for orphan drugs delivery, Prof. Dr. Basavaraj K. Nanjwade, KLE University College of Pharmacy, Belgavi/Belgaum, Karnataka, India.
Compliance shall never be the sole focus of GXP readiness preparations. Risks to business are numerous and varied and need to be considered in a holistic manner.
KCR: Post-Authorisation Safety Studies (PASS) - Is the Ongoing Surveillance a...KCR
Post-Authorisation Safety Studies (PASS)
Is the Ongoing Surveillance a Blessing Or a Curse?
28th DIA EuroMeeting
7 April 2016, Hamburg, Germany
Magdalena Matusiak, MPharm
Manager, Clinical Development
Pharmacovigilance Team Lead, KCR
GVP stands for Good Pharmacovigilance Practices, which are a set of guidelines and regulatory requirements that provide a framework for the conduct of pharmacovigilance activities. The GVP modules outline specific areas of pharmacovigilance and provide detailed guidance on various aspects. Here are the main GVP modules
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.
Identifying Safety Signals by Data Mining the FDA Adverse Event Reporting Sys...Perficient, Inc.
Ever since the European Union (EU) introduced new legislation that requires life sciences companies to proactively detect, prioritize, and evaluate safety signals, there has been an increased interest, not only from sponsors and CROs in the EU, but globally, in pharmacovigilance systems that can assist with the signal management process.
Perficient's Chris Wocosky, an expert in signal detection and management, shows how your organization can use Empirica Signal, Oracle's state-of-the-art signal detection system to data mine the existing FDA Adverse Event Reporting System (FAERS) to determine safety signals. This presentation and demonstration willhelp you bettter understand how this solution can be used in daily pharmacovigilance activities.
This Module provides guidance on planning and conducting the legally required audits, the role, context and management of pharmacovigilance audit activity.
The principles in this module are aligned with internationally accepted auditing standards, issued by relevant international auditing standardization organizations and support a risk-based approach to pharmacovigilance audits.
Regulatory requirements for orphan drugs delivery, Prof. Dr. Basavaraj K. Nanjwade, KLE University College of Pharmacy, Belgavi/Belgaum, Karnataka, India.
Compliance shall never be the sole focus of GXP readiness preparations. Risks to business are numerous and varied and need to be considered in a holistic manner.
KCR: Post-Authorisation Safety Studies (PASS) - Is the Ongoing Surveillance a...KCR
Post-Authorisation Safety Studies (PASS)
Is the Ongoing Surveillance a Blessing Or a Curse?
28th DIA EuroMeeting
7 April 2016, Hamburg, Germany
Magdalena Matusiak, MPharm
Manager, Clinical Development
Pharmacovigilance Team Lead, KCR
Data Privacy: The Hidden Beast within Mergers & AcquisitionsTrustArc
Today, growing an organization through Mergers & Acquisitions (M&A) has become a popular business practice. This can lead to great success but it can also cause a potential liability to the acquirer if global data privacy laws and regulations are not considered during the acquisition. Businesses that adopt this strategy need to be aware of how to handle the data involved in the acquisitions.
Between new and evolving data privacy laws, an increased focus on regulators, and increased liability on the acquirer, incorporating data privacy practices is necessary for the M&A transaction process.
IAM for the Masses: Managing Consumer Identities ForgeRock
Lori Robinson, Gartner's Research VP for Identity & Privacy Strategies, presents a keynote on managing consumer identities at the 2014 IRM Summit in Phoenix, Arizona.
[WSO2Con EU 2018] The Hybrid Integration Platform: Can You Be in Business Wit...WSO2
An "unintegrated digital business" is simply an oxymoron. Digitalization does empower organizations to innovate and disrupt, but entails tackling a daunting array of application, data, APIs, mobile apps, ecosystems and "things" integration issues. An enterprisewide hybrid integration platform to support these challenges is becoming a business utility such as networks, email and ERP: a precondition to be in business for organizations of any kind.
Ariba's director of solutions management for sell-side solutions will share our roadmap for exciting new functionality being developed for sellers in Ariba Discovery and the Ariba Network. Ariba Solution Town Halls were introduced at last year's Ariba LIVE, and the resounding feedback was to bring them back again for Ariba LIVE 2013! This is your chance to speak your mind about Ariba solutions in an open forum and be heard. After the roadmap and innovation overview, then the floor is all yours. We value your feedback and look forward to hearing what’s on your mind.
Unique Device Identification or UDI is a forever project. What's the best way for orthopaedic device companies to receive return on their investment? What best practices can be learned for a continually-smooth process? How can the data be leveraged to enhance your company’s value proposition? The true value of UDI is not in the identification number, but in the data that can be generated as a result of UDI. This session will provide attendees with an outline of the opportunities that manufacturers can leverage beyond implementation.
Learn to effectively and efficiently explore, evaluate, and confirm a shared understanding of refined backlog items using Structured conversations with the 7 Product Dimensions so they are ready for implementation.
(Presented at Agile Day New York City September 2018)
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
Anti ulcer drugs and their Advance pharmacology ||
Anti-ulcer drugs are medications used to prevent and treat ulcers in the stomach and upper part of the small intestine (duodenal ulcers). These ulcers are often caused by an imbalance between stomach acid and the mucosal lining, which protects the stomach lining.
||Scope: Overview of various classes of anti-ulcer drugs, their mechanisms of action, indications, side effects, and clinical considerations.
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
3. www.vigiserve.org www.vigilearn.org www.inopp.org
Parties to SDEA
INTERNAL
Affiliates/ Subsidiaries
Business Functions
Batch Release Site
Service Provider
Exploitant
VENDOR
With the Acquirer/Acquiree
M&A
Local/Contractual QPPV
Local Qualified Persons
Distributor/ Other Partners,
Co-Marketing/Co-Licensing
Innovator/RLD Owner
Business Partner
We will now learn about the management process for safety data exchange agreements, or SDEA.
Let us first understand the various stakeholders in SDEA management. The first stakeholder is the Pharmacovigilance or the drug safety department, that needs SDEA for ensuring and demonstrating compliance, as this is a regulatory requirement. The second stakeholder is the marketing or sales team of the marketing authorization holder. This team is responsible for establishing business relationship with the distributors. The next stakeholder is the business partner, which is required to ensure compliance with timely exchange of data. The last stakeholder is the legal team, that needs to ensure completeness of SDEA, and verify its executability.
All the four stakeholders need to work in sync with each other, and ensure appropriate collaboration.
We will now learn about the parties to SDEA. By party, we mean the partner with which the M A H needs to execute the SDEA. For convenience, we have divided these parties into five different groups. The first one is the business partner, that includes distributors, co-marketing or co-licensing partners, tender partners, or even innovator or RLD owner, in case of Para 4 filing related arrangements in the United states. Besides, this can even include Government or regulatory agencies. Second type pertains to local pharmacovigilance responsible persons, including the local or contractual QPPV. Third type pertains to vendors and service providers. This even includes the Exploitant in France. Next type pertains to Internal customers, or affiliates, subsidiaries, or even batch release sites. In some companies, SDEA is even executed with the business functions. The last type pertains to partners associated with merger and acquisitions. This is generally considered during the transition phase, between the two companies.
Whenever we think of an agreement, we would consider that it is between two parties. However, the number of parties may be three, or even four.
Bipartite SDEA is the commonest arrangement, where an SDEA is executed between two partners.
Tripartite SDEA, When there are three parties involved in a business arrangement. Example, When a company or M A H wants to outsource pharmacovigilance operations in France, and there is an Exploitant involved. A tripartite agreement may even be required when a distributor is incapable of fulfilling Pharmacovigilance obligations, where a local service provider may need to get involved.
Quadrapartite SDEA; This is a rare scenario where four parties are involved in executing an SDEA. Example, when there is an M A H, distributor, service provider and a local QPPV.
We will now learn about the various sections of an SDEA. There are broadly three sections in an SDEA. First is the safety section, that comprises of various pharmacovigilance related clauses, along with a responsibility matrix. This may even include some quality related parameters like audits, product complaints or even recalls, that may have a bearing on patient safety. The second section pertains to information exchange. This includes the Timelines and mechanism for Exchanging safety data, Reconciliation processes, Language and/or translation, medium of exchange, or even Data Privacy and business contingency planning. The third section pertains to administrative and legal aspects. These include the legal clauses, scope of agreement, products and territories, and even validity and revision timelines.
We will now learn about the types of SDEA. The different types include, Distribution, private label, licensing type, and service related. The distribution agreement is the most common type of SDEA, where there is a partner that distributes the company, or M A H product in one or more territories. Second type is the Private label SDEA, where a business partner my commercialize a product using its own label and packaging. These agreements may also be called as O L S agreements. In this case, business partner does not hold any product licence. The third type is the licensing arrangement. This may be out-licensing, or even in-licensing. Here, the business partner may or may not have exclusivity to commercialize a product. We can even have co-marketing arrangements, where more than one company may commercialize a product in the same territory. At times, the business partner may even hold a local license in that territory. The fourth type is the service arrangement, where we can have a vendor, which may be a service provider. This agreement may even be executed with company affiliates or subsidiaries. In case of merger and acquisitions, companies may engage into this kind of SDEA.
Who can Sign-off or execute the SDEA?
The Pharmacovigilance head or designee can sign off an SDEA only if he or she has been authorized by the company board If not, then the execution can be performed by any other authorized designee. In such cases, the designee may exercise caution and get the agreement vetted by the legal, before sign off.
The legal department is one of the most important stakeholders in SDEA management.
They should necessarily be involved in Drafting the template. The concept of 'one standard template' is hypothetical in the real sense, as there is no 'one size fits all' concept, and every business partner would suggest some changes before the agreement gets finalized.
Legal team is also involved in Review of SDEA, especially when it is the partner's template or there are amendments suggested by the partner.
What did we learn today?
We learn about the stakeholders in SDEA management along with their Roles & Responsibilities, parties to SDEA management, various components or sections of SDEA, the types of SDEA, and the process of e
We trust you found this useful.
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