The document discusses elements of a successful regulatory submission. It emphasizes close interaction between regulatory and development teams, generating submission-ready documents concurrently with development activities, creating a one-page registration plan and contact points with health authorities, developing a regulatory strategy aligned with business objectives, applying relevant guidelines throughout development, and using standard templates. Specific tips covered include developing project plans, document mapping and tracking, applying review processes, and understanding guidelines early in development. The overall message is that planning and coordination across functions is key to effective regulatory submissions.
This document provides an overview of regulatory affairs for drugs. It defines key terms like regulatory affairs, dossier, CTD, eCTD, DMF, NDA, ANDA, and INDA. It describes the role of regulatory affairs experts in guiding product development according to regulatory requirements, compiling dossiers for submission, and ensuring post-marketing compliance. The document outlines a 10 step process for regulatory product development and regulatory submission preparation. It also discusses quality management systems for regulatory compliance and the role of regulatory affairs in marketing and advertising compliance.
Vanessa Tasso has over 15 years of experience in healthcare and aerospace operations, specializing in clinical affairs, regulatory compliance, and marketing. She has a proven track record of optimizing business processes, managing clinical trials, gaining regulatory approvals, raising funds, and commercializing new medical technologies. Notable achievements include accelerating patient enrollment in a clinical trial by 500% ahead of schedule and raising $44M for an IPO. She is skilled in developing compliant documentation, navigating international trials, and creating compelling marketing materials to promote new treatments.
The document proposes new organizational policies and guidelines to address benchmark underperformances in readmission rates, patient falls, and hospital-acquired infections. It analyzes how the underperformances negatively impact quality of care and could lead to regulatory and financial penalties if unaddressed. Evidence-based strategies are recommended to form the basis of new policies on standardized discharge processes, hourly rounding using call lights, and mandatory hand hygiene. Implementation would require approval from regulatory bodies and involvement of stakeholders like physicians, nurses, and all hospital staff to ensure success. Resources and the hospital's expansion may pose challenges that require consideration.
Alison Kocanda has over 15 years of experience in the pharmaceutical industry marketing managed markets and developing payer strategies. She is currently the Director at Shire Pharmaceuticals where she led the payer launch strategy for ADYNOVATE, resulting in over 90% unconstrained coverage. Previously she held marketing roles at Takeda developing payer programs and medical education strategies for multiple therapeutic areas. She has expertise in developing value propositions, contracting strategies, and programs to improve access and reimbursement for products.
£1,000.00
Manager: £1,500.00
Strategic Consultant
£1,500.00
Medical Consultant
£1,500.00
Legal Consultant
£1,500.00
Communication Consultant
£1,500.00
Project Manager
£1,000.00
Administrative Support
£500.00
08/02/2014 confidential
35
Our Costing Procedure
1. Initial meeting to understand the need
2. Proposal of the appropriate level of advice
3. Estimate of required time and team
4. Costing based on our grid
5.
This document provides a summary of Maria Bloodgood's professional experience and qualifications. She has over 20 years of experience in project management roles in the pharmaceutical industry, focusing on clinical development and medical affairs. Her most recent role is as a Global Project Manager at Eurofins Central Laboratory, where she is responsible for managing projects and ensuring they are completed on time, on budget, and meeting quality standards. She has extensive experience managing clinical studies and programs across multiple therapeutic areas.
The document discusses implementing the principles of the Paris Declaration for research for health systems. It recommends developing indicators to assess the intended and unintended outcomes and impact of implementation. Partner countries and donors should share assessment results and adapt strategies accordingly to maximize countries' benefits.
Monitoring Scale-up of Health Practices and InterventionsMEASURE Evaluation
This guide provides information to help monitor the scale-up of health practices and interventions. It introduces the guide and its objectives, which are to provide background on monitoring scale-up initiatives. The guide includes a rationale for monitoring scale-up, a readiness assessment, 10 considerations for monitoring scale-up such as defining objectives and selecting indicators, and appendices with case studies and frameworks for scaling up health interventions. The goal is to create a practical resource that can help effectively monitor and evaluate the scale-up process.
This document provides an overview of regulatory affairs for drugs. It defines key terms like regulatory affairs, dossier, CTD, eCTD, DMF, NDA, ANDA, and INDA. It describes the role of regulatory affairs experts in guiding product development according to regulatory requirements, compiling dossiers for submission, and ensuring post-marketing compliance. The document outlines a 10 step process for regulatory product development and regulatory submission preparation. It also discusses quality management systems for regulatory compliance and the role of regulatory affairs in marketing and advertising compliance.
Vanessa Tasso has over 15 years of experience in healthcare and aerospace operations, specializing in clinical affairs, regulatory compliance, and marketing. She has a proven track record of optimizing business processes, managing clinical trials, gaining regulatory approvals, raising funds, and commercializing new medical technologies. Notable achievements include accelerating patient enrollment in a clinical trial by 500% ahead of schedule and raising $44M for an IPO. She is skilled in developing compliant documentation, navigating international trials, and creating compelling marketing materials to promote new treatments.
The document proposes new organizational policies and guidelines to address benchmark underperformances in readmission rates, patient falls, and hospital-acquired infections. It analyzes how the underperformances negatively impact quality of care and could lead to regulatory and financial penalties if unaddressed. Evidence-based strategies are recommended to form the basis of new policies on standardized discharge processes, hourly rounding using call lights, and mandatory hand hygiene. Implementation would require approval from regulatory bodies and involvement of stakeholders like physicians, nurses, and all hospital staff to ensure success. Resources and the hospital's expansion may pose challenges that require consideration.
Alison Kocanda has over 15 years of experience in the pharmaceutical industry marketing managed markets and developing payer strategies. She is currently the Director at Shire Pharmaceuticals where she led the payer launch strategy for ADYNOVATE, resulting in over 90% unconstrained coverage. Previously she held marketing roles at Takeda developing payer programs and medical education strategies for multiple therapeutic areas. She has expertise in developing value propositions, contracting strategies, and programs to improve access and reimbursement for products.
£1,000.00
Manager: £1,500.00
Strategic Consultant
£1,500.00
Medical Consultant
£1,500.00
Legal Consultant
£1,500.00
Communication Consultant
£1,500.00
Project Manager
£1,000.00
Administrative Support
£500.00
08/02/2014 confidential
35
Our Costing Procedure
1. Initial meeting to understand the need
2. Proposal of the appropriate level of advice
3. Estimate of required time and team
4. Costing based on our grid
5.
This document provides a summary of Maria Bloodgood's professional experience and qualifications. She has over 20 years of experience in project management roles in the pharmaceutical industry, focusing on clinical development and medical affairs. Her most recent role is as a Global Project Manager at Eurofins Central Laboratory, where she is responsible for managing projects and ensuring they are completed on time, on budget, and meeting quality standards. She has extensive experience managing clinical studies and programs across multiple therapeutic areas.
The document discusses implementing the principles of the Paris Declaration for research for health systems. It recommends developing indicators to assess the intended and unintended outcomes and impact of implementation. Partner countries and donors should share assessment results and adapt strategies accordingly to maximize countries' benefits.
Monitoring Scale-up of Health Practices and InterventionsMEASURE Evaluation
This guide provides information to help monitor the scale-up of health practices and interventions. It introduces the guide and its objectives, which are to provide background on monitoring scale-up initiatives. The guide includes a rationale for monitoring scale-up, a readiness assessment, 10 considerations for monitoring scale-up such as defining objectives and selecting indicators, and appendices with case studies and frameworks for scaling up health interventions. The goal is to create a practical resource that can help effectively monitor and evaluate the scale-up process.
What’s Next in US Payor Communications: The Impact of FDA's Proposed Guidance...Nathan White, CPC
The recent enactment of the 21st Century Cures Act has profound immediate and long-term implications for development and communication of HEOR/RWE in the US, particularly in relation to communications with payors about healthcare economic information (HCEI). In January, the FDA released draft guidance for public comment to outline its thinking around communication to payors of HCEI, but there are still unanswered questions to be addressed in the final guidance. Industry will need to quickly establish new policies and procedures to maintain compliance with the new regulations, especially in relation to OPDP submission requirements – a steep transition from a space that has largely been unregulated.
The document provides information about the 7th Pharmacovigilance 2014 conference happening on November 21st, 2014 in Mumbai, India. The conference will discuss ensuring safer drugs to market through analyzing developments in pharmacovigilance, drug safety, and risk management. It will feature key speakers from various pharmaceutical companies and have panels on topics like improving patient safety, using new technologies in pharmacovigilance, and keeping updated on opportunities in drug safety research. The event aims to help pharmaceutical and biotech companies improve their pharmacovigilance strategies and compliance.
Clinical evaluation and the latest 2016 guidelineGRCTS
This “General Guidance” document promotes a common approach to clinical evaluation for "medical devices regulated by directives 90/385/EEC and 93/42/EEC. It does not concern in vitro diagnostic devices. The depth and extent of clinical evaluations should be flexible and appropriate to the nature, intended purpose, and risks of the device in question.
The document discusses the FDA's Critical Path Initiative, which aims to improve the process of drug development and evaluation. It notes that the current drug development process is becoming a bottleneck. The initiative seeks to identify specific projects through a science-driven, shared effort between stakeholders to improve efficiency. The FDA must lead efforts to question assumptions that slow new product development and identify more efficient alternatives. The document also discusses two proposed projects - to create a "current state" process map to identify opportunities for improvement, and to develop a knowledge management system using ICH Q8 to ensure appropriate connectivity between all regulatory disciplines involved in drug development and review.
Report on the progress of NAAF’s Patient-Reported Outcome (PRO) Consortium to develop a single, consensus-defined PRO instrument that can be shared across industry partners and other ongoing initiatives to incorporate the voice of the patient in alopecia areata research.
Partnerships in Health Innovation: Expanding Paradigms of Private Profit and ...Shift Health
Public-private partnerships (P3s) have become an increasingly pivotal—almost doctrinal—driver of R&D across the health sciences. But for all the advantages that have made P3s increasingly inevitable, these partnerships have not become less complex.
INTRODUCTIONThe increasing discussion about rising healthcare co.docxvrickens
INTRODUCTION
The increasing discussion about rising healthcare cost is fuelled by reports that General Motors paid more for healthcare than for steel per vehicle in 2004,1 and Starbucks paid more for health insurance than for coffee in 2005.2 The continuing rise in development costs for drugs has increased pressure on R&D organisations to contribute to higher efficiency in the overall process of coming up with new drugs.
In the last few years the industry has made significant efforts to address these challenges3 and to increase the productivity of the drug development process. Some of the initiatives have without doubt led to considerable improvements. Examples are the earlier determination of a drug's toxicology profile and early tests to investigate the suitability of a new drug candidate for oral administration or once a day dosing. The question is no longer how good we are in what we are doing but whether we are doing the right things. Further improvements of the overall process should shift from attempts of enhancing effectiveness to a greater emphasis on the efficiency of the processes applied.
In this context a lot of emphasis is put on portfolio management. In the broadest definition, portfolio management describes the process of maximising the value of R&D portfolios through proper resource allocation. This requires an alignment of portfolio management with strategic business objectives. Such objectives should not only be general (e.g., innovation) and quantitative (eg ROI or sales targets). They should also define disease areas of interest, clearly outline the remaining medical needs, and specify the indications that are considered worth pursuing. This will enable decision makers and functional R&D managers to identify projects with both strategic fit and a high value proposition. Depending on the size of the organisation, either a corporate or therapeutic area strategies need to be developed, approved, and endorsed by the entire organisation.
Value-driven project and portfolio management implies quantitative financial and risk analysis of individual projects and overall portfolios. Such analyses elucidate options for improving the value and risk structure of individual projects on the one hand and therapeutic areas or overall corporate portfolios on the other hand. They are applicable and relevant to companies of any size. Value-driven project and portfolio management is a methodology enabling the alignment of project decisions with corporate strategy and defined business objectives.
Although portfolio management has been applied in the financial industry for many years and Harry Markowitz was honoured with the Nobel Prize for outlining this concept it was only around the end of the last century that the application of value-driven portfolio management in the pharmaceutical industry was published. 4 Around the same time, an investigation across various industries provided evidence that portfolio management based on quantitative fin ...
Huron Webinar_Government Pricing_A Top Priority for the Compliance Department...Clay Willis
The webinar provided an overview of government pricing compliance for pharmaceutical manufacturers. It discussed the importance of government pricing calculations and reporting for Medicaid, Medicare, and other government programs. Recent settlements for inaccurate reporting were also reviewed. The presentation emphasized that an effective compliance program should incorporate the 7 elements from the OIG, including policies, training, auditing, and responding to issues. It was recommended that companies conduct regular diagnostics of their government pricing functions to assess risks and ensure compliance. Key questions for compliance departments to consider about their own programs were also provided.
James D. Terish Bin has over 14 years of experience in the pharmaceutical industry, holding roles in analytical development, bioequivalence studies, quality management, and business development. He has a Doctorate in Pharmacy and has led teams of over 100 people, developing new services, growing businesses, and ensuring regulatory compliance. Currently he is the AGM of Operations at Sequent Research Limited, leading their bioanalytical and analytical services across multiple locations.
7th Pharmacovigilance 2014 “Ensuring safer drugs to market by analyzing latest developments in pharmacovigilance, drug safety and risk management" 21st November 2014, Kohinoor Continental Hotel, Mumbai, India Greetings from Virtue Insight, I am happy to invite you and your colleagues to be a sponsor / delegate for our upcoming conference. The “Ensuring safer drugs to market by analyzing latest developments in pharmacovigilance, drug safety and risk management” at 7th Pharmacovigilance 2014 on 21st November 2014, Kohinoor Continental Hotel, Mumbai, India.Contact:-Tel: +91 9677590192 Email: dinesh@virtueinsight.co.in
The document provides information about the 7th Pharmacovigilance conference taking place on November 21st, 2014 in Mumbai, India. The conference will discuss ensuring safer drugs through analyzing developments in pharmacovigilance, drug safety, and risk management. Key speakers from various pharmaceutical companies will discuss topics like signal detection, risk management plans, data collection and management, and regulatory expectations and updates. The conference is aimed at professionals in pharmacovigilance, drug safety, clinical research, and regulatory affairs. It will provide a platform for stakeholders to discuss best practices and challenges in the field.
I am writing to make you aware of our upcoming event:- 7th Pharmacovigilance 2014 taking place on 21st November 2014, Kohinoor Continental Hotel, Mumbai, India.
The document discusses balancing innovation and risk in pharmaceutical R&D operations. It argues that through scientific advancement and rethinking R&D processes, risk and return on investment can be balanced. It defines different types of innovation and discusses why companies innovate. The document also examines how to create transparency in risk and costs through integrated data-driven analysis and decision making. It provides examples of how companies have restructured R&D operations and integrated external partners to improve innovation.
Shift Health co-hosted a Product Development Boot Camp with the Global HIV Vaccine Enterprise. The Boot Camp afforded workshop participants an opportunity to discuss best practices, to learn from the experience of other experts and to create an enduring resource and toolkit that will serve the HIV vaccine field and beyond.
Product development refers to the multifaceted, long-term, highly regulated process that brings promising new drugs, vaccines and medical devices to the populations who most need them. In fields such as HIV vaccine development, where the absence of commercial incentives can make it difficult for companies to lead this process on their own, inventors need to work in partnership with diverse stakeholders and funders to maximize the social and economic impact of their research.
Ryan Wiley, PhD, President at Shift Health, delivered an overview of product development partnerships, which exhibit three common elements:
Defined governance mechanisms that enable appropriate participation in decision-making
Disciplined approach to communication among partners and with stakeholders
IP policies that balance the needs of individual partners with the objectives of the partnership.
Writing SOPs or procedural documents can be challenging at times. However, writing SOPs is overall a straightforward process. However, enforcing what you already created and implemented in the pipeline is another story. The term SOP is very obvious. We have seen "clearly written description of how specific tasks are to be done." Another satisfactory definition would be "detailed written instructions that achieve the uniformity of the performance of a specific function." Is the firm doing what the regulations specify? Is the firm doing what their procedures specify? If you are medical device or a pharmaceutical manufacturer, these definitions come as no surprise because when it comes to FDA regulations and guidance documents "establish" means to define, to document (in writing or electronically) and to implement.
The Health Finance and Governance (HFG) Project organized a multi-country workshop to support policymakers from public health and finance agencies in developing concrete action plans for mobilizing domestic resources for health. This presentation on the HFG toolkit addresses gaps in the Ministry of Health and Ministry of Finance relationship. The toolkit presents a set of strategies, self assessment methodologies and performance management processes to help the MOH better manage their own resources and to help foster more effective coordination between the MOH and the MOF.
Highlights from ExL Pharma's 12th Investigator Initiated TrialsExL Pharma
- ExLPharma holds annual conferences on investigator-initiated trials (IITs) to discuss governance models, planning, operations, and the role of medical science liaisons (MSLs).
- Key topics included developing a review committee and charter, strategic planning documents, budgeting, standard operating procedures, and metrics to measure program success.
- The role of MSLs in IITs is to provide scientific feedback, study information, and liaise across functions like medical information and clinical development to support investigators.
- Prioritizing IITs involves aligning them with product strategies and evaluating proposals based on strategic fit, scientific design, and investigator/site capabilities.
Bob Wick is a registered nurse seeking a new career opportunity in healthcare or pharmaceuticals. He has over 20 years of experience in various roles including management, sales, clinical applications, and community outreach. His most recent roles include serving as a Central Nervous System Sales Specialist and Community Service Liaison. He is seeking a new position where he can utilize his leadership, communication, and relationship building skills.
What’s Next in US Payor Communications: The Impact of FDA's Proposed Guidance...Nathan White, CPC
The recent enactment of the 21st Century Cures Act has profound immediate and long-term implications for development and communication of HEOR/RWE in the US, particularly in relation to communications with payors about healthcare economic information (HCEI). In January, the FDA released draft guidance for public comment to outline its thinking around communication to payors of HCEI, but there are still unanswered questions to be addressed in the final guidance. Industry will need to quickly establish new policies and procedures to maintain compliance with the new regulations, especially in relation to OPDP submission requirements – a steep transition from a space that has largely been unregulated.
The document provides information about the 7th Pharmacovigilance 2014 conference happening on November 21st, 2014 in Mumbai, India. The conference will discuss ensuring safer drugs to market through analyzing developments in pharmacovigilance, drug safety, and risk management. It will feature key speakers from various pharmaceutical companies and have panels on topics like improving patient safety, using new technologies in pharmacovigilance, and keeping updated on opportunities in drug safety research. The event aims to help pharmaceutical and biotech companies improve their pharmacovigilance strategies and compliance.
Clinical evaluation and the latest 2016 guidelineGRCTS
This “General Guidance” document promotes a common approach to clinical evaluation for "medical devices regulated by directives 90/385/EEC and 93/42/EEC. It does not concern in vitro diagnostic devices. The depth and extent of clinical evaluations should be flexible and appropriate to the nature, intended purpose, and risks of the device in question.
The document discusses the FDA's Critical Path Initiative, which aims to improve the process of drug development and evaluation. It notes that the current drug development process is becoming a bottleneck. The initiative seeks to identify specific projects through a science-driven, shared effort between stakeholders to improve efficiency. The FDA must lead efforts to question assumptions that slow new product development and identify more efficient alternatives. The document also discusses two proposed projects - to create a "current state" process map to identify opportunities for improvement, and to develop a knowledge management system using ICH Q8 to ensure appropriate connectivity between all regulatory disciplines involved in drug development and review.
Report on the progress of NAAF’s Patient-Reported Outcome (PRO) Consortium to develop a single, consensus-defined PRO instrument that can be shared across industry partners and other ongoing initiatives to incorporate the voice of the patient in alopecia areata research.
Partnerships in Health Innovation: Expanding Paradigms of Private Profit and ...Shift Health
Public-private partnerships (P3s) have become an increasingly pivotal—almost doctrinal—driver of R&D across the health sciences. But for all the advantages that have made P3s increasingly inevitable, these partnerships have not become less complex.
INTRODUCTIONThe increasing discussion about rising healthcare co.docxvrickens
INTRODUCTION
The increasing discussion about rising healthcare cost is fuelled by reports that General Motors paid more for healthcare than for steel per vehicle in 2004,1 and Starbucks paid more for health insurance than for coffee in 2005.2 The continuing rise in development costs for drugs has increased pressure on R&D organisations to contribute to higher efficiency in the overall process of coming up with new drugs.
In the last few years the industry has made significant efforts to address these challenges3 and to increase the productivity of the drug development process. Some of the initiatives have without doubt led to considerable improvements. Examples are the earlier determination of a drug's toxicology profile and early tests to investigate the suitability of a new drug candidate for oral administration or once a day dosing. The question is no longer how good we are in what we are doing but whether we are doing the right things. Further improvements of the overall process should shift from attempts of enhancing effectiveness to a greater emphasis on the efficiency of the processes applied.
In this context a lot of emphasis is put on portfolio management. In the broadest definition, portfolio management describes the process of maximising the value of R&D portfolios through proper resource allocation. This requires an alignment of portfolio management with strategic business objectives. Such objectives should not only be general (e.g., innovation) and quantitative (eg ROI or sales targets). They should also define disease areas of interest, clearly outline the remaining medical needs, and specify the indications that are considered worth pursuing. This will enable decision makers and functional R&D managers to identify projects with both strategic fit and a high value proposition. Depending on the size of the organisation, either a corporate or therapeutic area strategies need to be developed, approved, and endorsed by the entire organisation.
Value-driven project and portfolio management implies quantitative financial and risk analysis of individual projects and overall portfolios. Such analyses elucidate options for improving the value and risk structure of individual projects on the one hand and therapeutic areas or overall corporate portfolios on the other hand. They are applicable and relevant to companies of any size. Value-driven project and portfolio management is a methodology enabling the alignment of project decisions with corporate strategy and defined business objectives.
Although portfolio management has been applied in the financial industry for many years and Harry Markowitz was honoured with the Nobel Prize for outlining this concept it was only around the end of the last century that the application of value-driven portfolio management in the pharmaceutical industry was published. 4 Around the same time, an investigation across various industries provided evidence that portfolio management based on quantitative fin ...
Huron Webinar_Government Pricing_A Top Priority for the Compliance Department...Clay Willis
The webinar provided an overview of government pricing compliance for pharmaceutical manufacturers. It discussed the importance of government pricing calculations and reporting for Medicaid, Medicare, and other government programs. Recent settlements for inaccurate reporting were also reviewed. The presentation emphasized that an effective compliance program should incorporate the 7 elements from the OIG, including policies, training, auditing, and responding to issues. It was recommended that companies conduct regular diagnostics of their government pricing functions to assess risks and ensure compliance. Key questions for compliance departments to consider about their own programs were also provided.
James D. Terish Bin has over 14 years of experience in the pharmaceutical industry, holding roles in analytical development, bioequivalence studies, quality management, and business development. He has a Doctorate in Pharmacy and has led teams of over 100 people, developing new services, growing businesses, and ensuring regulatory compliance. Currently he is the AGM of Operations at Sequent Research Limited, leading their bioanalytical and analytical services across multiple locations.
7th Pharmacovigilance 2014 “Ensuring safer drugs to market by analyzing latest developments in pharmacovigilance, drug safety and risk management" 21st November 2014, Kohinoor Continental Hotel, Mumbai, India Greetings from Virtue Insight, I am happy to invite you and your colleagues to be a sponsor / delegate for our upcoming conference. The “Ensuring safer drugs to market by analyzing latest developments in pharmacovigilance, drug safety and risk management” at 7th Pharmacovigilance 2014 on 21st November 2014, Kohinoor Continental Hotel, Mumbai, India.Contact:-Tel: +91 9677590192 Email: dinesh@virtueinsight.co.in
The document provides information about the 7th Pharmacovigilance conference taking place on November 21st, 2014 in Mumbai, India. The conference will discuss ensuring safer drugs through analyzing developments in pharmacovigilance, drug safety, and risk management. Key speakers from various pharmaceutical companies will discuss topics like signal detection, risk management plans, data collection and management, and regulatory expectations and updates. The conference is aimed at professionals in pharmacovigilance, drug safety, clinical research, and regulatory affairs. It will provide a platform for stakeholders to discuss best practices and challenges in the field.
I am writing to make you aware of our upcoming event:- 7th Pharmacovigilance 2014 taking place on 21st November 2014, Kohinoor Continental Hotel, Mumbai, India.
The document discusses balancing innovation and risk in pharmaceutical R&D operations. It argues that through scientific advancement and rethinking R&D processes, risk and return on investment can be balanced. It defines different types of innovation and discusses why companies innovate. The document also examines how to create transparency in risk and costs through integrated data-driven analysis and decision making. It provides examples of how companies have restructured R&D operations and integrated external partners to improve innovation.
Shift Health co-hosted a Product Development Boot Camp with the Global HIV Vaccine Enterprise. The Boot Camp afforded workshop participants an opportunity to discuss best practices, to learn from the experience of other experts and to create an enduring resource and toolkit that will serve the HIV vaccine field and beyond.
Product development refers to the multifaceted, long-term, highly regulated process that brings promising new drugs, vaccines and medical devices to the populations who most need them. In fields such as HIV vaccine development, where the absence of commercial incentives can make it difficult for companies to lead this process on their own, inventors need to work in partnership with diverse stakeholders and funders to maximize the social and economic impact of their research.
Ryan Wiley, PhD, President at Shift Health, delivered an overview of product development partnerships, which exhibit three common elements:
Defined governance mechanisms that enable appropriate participation in decision-making
Disciplined approach to communication among partners and with stakeholders
IP policies that balance the needs of individual partners with the objectives of the partnership.
Writing SOPs or procedural documents can be challenging at times. However, writing SOPs is overall a straightforward process. However, enforcing what you already created and implemented in the pipeline is another story. The term SOP is very obvious. We have seen "clearly written description of how specific tasks are to be done." Another satisfactory definition would be "detailed written instructions that achieve the uniformity of the performance of a specific function." Is the firm doing what the regulations specify? Is the firm doing what their procedures specify? If you are medical device or a pharmaceutical manufacturer, these definitions come as no surprise because when it comes to FDA regulations and guidance documents "establish" means to define, to document (in writing or electronically) and to implement.
The Health Finance and Governance (HFG) Project organized a multi-country workshop to support policymakers from public health and finance agencies in developing concrete action plans for mobilizing domestic resources for health. This presentation on the HFG toolkit addresses gaps in the Ministry of Health and Ministry of Finance relationship. The toolkit presents a set of strategies, self assessment methodologies and performance management processes to help the MOH better manage their own resources and to help foster more effective coordination between the MOH and the MOF.
Highlights from ExL Pharma's 12th Investigator Initiated TrialsExL Pharma
- ExLPharma holds annual conferences on investigator-initiated trials (IITs) to discuss governance models, planning, operations, and the role of medical science liaisons (MSLs).
- Key topics included developing a review committee and charter, strategic planning documents, budgeting, standard operating procedures, and metrics to measure program success.
- The role of MSLs in IITs is to provide scientific feedback, study information, and liaise across functions like medical information and clinical development to support investigators.
- Prioritizing IITs involves aligning them with product strategies and evaluating proposals based on strategic fit, scientific design, and investigator/site capabilities.
Bob Wick is a registered nurse seeking a new career opportunity in healthcare or pharmaceuticals. He has over 20 years of experience in various roles including management, sales, clinical applications, and community outreach. His most recent roles include serving as a Central Nervous System Sales Specialist and Community Service Liaison. He is seeking a new position where he can utilize his leadership, communication, and relationship building skills.
Muktapishti is a traditional Ayurvedic preparation made from Shoditha Mukta (Purified Pearl), is believed to help regulate thyroid function and reduce symptoms of hyperthyroidism due to its cooling and balancing properties. Clinical evidence on its efficacy remains limited, necessitating further research to validate its therapeutic benefits.
TEST BANK For An Introduction to Brain and Behavior, 7th Edition by Bryan Kol...rightmanforbloodline
TEST BANK For An Introduction to Brain and Behavior, 7th Edition by Bryan Kolb, Ian Q. Whishaw, Verified Chapters 1 - 16, Complete Newest Versio
TEST BANK For An Introduction to Brain and Behavior, 7th Edition by Bryan Kolb, Ian Q. Whishaw, Verified Chapters 1 - 16, Complete Newest Version
TEST BANK For An Introduction to Brain and Behavior, 7th Edition by Bryan Kolb, Ian Q. Whishaw, Verified Chapters 1 - 16, Complete Newest Version
Rasamanikya is a excellent preparation in the field of Rasashastra, it is used in various Kushtha Roga, Shwasa, Vicharchika, Bhagandara, Vatarakta, and Phiranga Roga. In this article Preparation& Comparative analytical profile for both Formulationon i.e Rasamanikya prepared by Kushmanda swarasa & Churnodhaka Shodita Haratala. The study aims to provide insights into the comparative efficacy and analytical aspects of these formulations for enhanced therapeutic outcomes.
Adhd Medication Shortage Uk - trinexpharmacy.comreignlana06
The UK is currently facing a Adhd Medication Shortage Uk, which has left many patients and their families grappling with uncertainty and frustration. ADHD, or Attention Deficit Hyperactivity Disorder, is a chronic condition that requires consistent medication to manage effectively. This shortage has highlighted the critical role these medications play in the daily lives of those affected by ADHD. Contact : +1 (747) 209 – 3649 E-mail : sales@trinexpharmacy.com
Does Over-Masturbation Contribute to Chronic Prostatitis.pptxwalterHu5
In some case, your chronic prostatitis may be related to over-masturbation. Generally, natural medicine Diuretic and Anti-inflammatory Pill can help mee get a cure.
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...Oleg Kshivets
Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
- Video recording of this lecture in English language: https://youtu.be/kqbnxVAZs-0
- Video recording of this lecture in Arabic language: https://youtu.be/SINlygW1Mpc
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Part II - Body Grief: Losing parts of ourselves and our identity before, duri...
581ce1598f7df.pdf
1. YATIKA KOHLI PH.D.
DIRECTOR, RA BIOPHARMACEUTICALS.
APOTEX INC.
PREPARING FOR YOUR
REGULATORY SUBMISSION -
TIPS FOR EFFECTIVE
REGULATORY STRATEGY
1 CAPRA EDUCATION DAY, June 4
2014
2. Disclaimer
CAPRA EDUCATION DAY, June 4 2014
2
The information and views expressed in this
presentation are my personal views, and may
not be understood or quoted as being made
on behalf of Apotex
3. Elements of Successful Regulatory Submission
Elements of
successful
Regulatory
submission
Close interaction with
project team and
following project
plans through out
development process
Generation of
submission ready
documents in
conjunction with
completion of
development
activities
Creation of one page
registration plan with
defined contact points
with concerned health
authorities
Creation of regulatory
strategy to align
regulatory activities
with Business
objectives
Application of
applicable guidelines
throughout the
development process
Use of standard
templates for
document creation,
review and tracking
3 CAPRA EDUCATION DAY, June 4 2014
4. Elements of Successful Regulatory Submission
Elements
of
successful
Regulatory
submission
Close interaction
with project team
and following
project plans
through out
development
process
Generation of
submission ready
documents in
conjunction with
completion of
development
activities
Creation of one
page registration
plan with defined
contact points with
concerned health
authorities
Creation of
regulatory
strategy to align
regulatory
activities with
Business
objectives
Application of
applicable
guidelines
throughout the
development
process
Use of standard
templates for
document creation,
review and
tracking
4 CAPRA EDUCATION DAY, June 4 2014
5. Creation of Regulatory Strategy
CAPRA EDUCATION DAY, June 4 2014
5
Goal
A well- developed and thought out plan that is
balanced, realistic and achievable to support the
organization’s mission and vision.
Purpose
To define the plan for developing the product with the goal of
obtaining regulatory approval in desired markets and lifecycle
management/maintenance post approval
To establish GO/NO GO decision points
To outline which path to take, with the background and the
rationale of why a specific path is selected or recommended
Creation of
regulatory
strategy to
align
regulatory
activities with
Business
objectives
6. Elements of Regulatory Strategy - 1/3
Target Product Profile
Targeted market(s)
Targeted indication(s)
Targeted Product composition, strengths, presentation
Targeted shelf life and storage conditions
Development program and Overall project timelines
Regional vs. global development
Regulatory requirements in the jurisdictions of interest
Understanding of constraints, if any, to market the product in
country(ies) of interest
6 CAPRA EDUCATION DAY, June 4 2014
Creation of
regulatory
strategy to
align
regulatory
activities with
Business
objectives
7. Elements of Regulatory Strategy - 2/3
Quality Aspects of development program
Manufacturer – Who, where?
Manufacturing Capabilities – small scale, commercial scale
Timing of scale-up , if any
Analytics – Applicable monographs (USP/Ph.Eur.);
Compendial methods; Who, where?
Non-Clinical Program
Regional vs. global development
Regulatory requirements in the jurisdictions of interest
Understanding of constraints, if any, to market the product in
country(ies) of interest
7 CAPRA EDUCATION DAY, June 4 2014
Creation of
regulatory
strategy to
align
regulatory
activities with
Business
objectives
8. Elements of Regulatory Strategy - 3/3
Clinical program
Regional vs. global development
Phase(s) and # of clinical trials
Single vs. multi-country / Single vs. multicenter study(ies)
Country(ies) where the study(ies) will be conducted
Type of clinical trial application - CTA/IND/IMPD
High level study design and sample size
Comparative vs. non-comparative
Comparator – placebo/standard of care/reference product
8 CAPRA EDUCATION DAY, June 4 2014
Creation of
regulatory
strategy to
align
regulatory
activities with
Business
objectives
9. Influences on Regulatory Strategy
CAPRA EDUCATION DAY, June 4 2014
9
Regulatory Strategy
Competitive Products
Technology
Patients
Patient Advocacy Groups
Etc.
Regulatory Affairs
Product Development
Manufacturing
Etc.
Regulatory Authorities
Guidelines
Standards Organizations
Etc.
External Influences
Regulatory Influences
Internal Influences
Creation of
regulatory
strategy to
align
regulatory
activities with
Business
objectives
10. CAPRA EDUCATION DAY, June 4 2014
10
Market objectives (e.g., desired claims and markets)
Where is the company positioned in the space – leader, fast follower,
me-too?
The definition of success
Business drivers
Degree of development work already completed
Previous experiences with similar products
Depth of understanding of technology and mechanisms of action
Availability of resources (time, staff, expertise, and money)
Interactions with other business/development projects
Organization of the business (e.g., in-house vs. outsourced development
capability)
Previous interactions with regulatory authorities
Interaction with reimbursement strategy
Planning evidence development
Regulatory Strategy – Internal Factors
Creation of
regulatory
strategy to
align
regulatory
activities with
Business
objectives
11. CAPRA EDUCATION DAY, June 4 2014
11
The competitive landscape
Trends in the domestic and global practice of medicine and standard of
care
Regulatory or market concerns with particular product categories or
industry sectors
Current and evolving regulatory environment – submissions
procedures, classification changes, evidence requirements, etc.
Health economics of treatment/device and associated evidence and
comparative effectiveness expectations
Current and evolving reimbursement policies
Concerns over specific materials, components, treatment, etc.
Prevalence and consequences of off-label use
Regulatory Strategy – External Factors
Creation of
regulatory
strategy to
align
regulatory
activities with
Business
objectives
12. Competitive Landscape
Who are the potential players? Real vs. potential
competitor(s)?
Where are they located?
Where are they with their respective development(s)?
If ahead, how far ahead? If behind, how far behind?
Regulatory Landscape and Framework?
Regulatory environment – is it established, developing,
changing, evolving?
New requirements/legislations/regulations available vs.
projected?
Review requirements/ timing/ performance?
12 CAPRA EDUCATION DAY, June 4 2014
Regulatory Strategy – External Factors
Creation of
regulatory
strategy to
align
regulatory
activities with
Business
objectives
13. Elements of Successful Regulatory Submission
Elements
of
successful
Regulatory
submission
Close interaction
with project
team and
following project
plans through
out development
process
Generation of
submission
ready documents
in conjunction
with completion
of development
activities
Creation of one
page
registration plan
with defined
contact points
with concerned
health
authorities
Creation of
regulatory
strategy to align
regulatory
activities with
Business
objectives
Application of
applicable
guidelines
throughout the
development
process
Use of standard
templates for
document
creation, review
and tracking
13 CAPRA EDUCATION DAY, June 4 2014
14. One Page Registration Plan
CAPRA EDUCATION DAY, June 4 2014
14
Goal
A well- developed and thought out plan that describes the
specific steps and action required to successfully meet the
regulatory strategy objectives
Purpose
To have a high level understanding of the product development
program
To define the milestones for health authorty(ies) contact during the
development program
Common and consistent means of communication internally within
the project and functional teams
Contains the specific elements required to assemble the regulatory
submission
Creation of one
page registration
plan with defined
contact points
with concerned
health
authorities
15. Regulatory Strategy – Points for Consideration
CAPRA EDUCATION DAY, June 4 2014
15
Regulatory strategy is a living document – you
must EXPECT change
Some examples:
Regulations evolve and change
Based on additional experience and/or information
agencies can change their view on the subject
New intelligence on similar product
Change in target label or markets
Pressure from patients, advocacy groups or media
16. Regulatory Strategy – Points for Consideration
CAPRA EDUCATION DAY, June 4 2014
16
Definition of scope
Defining and differentiating near-term and long-term
objectives
Bridging elements and dependencies between the
business and regulatory strategies
Keeping a focus on the end goal – clinical, product
quality, and business
Identifying influencing elements (internal and external)
Understanding of different perspectives
coordinated into a meaningful, effective, resilient
guiding strategy
17. Regulatory Strategy – Execution and maintenance
CAPRA EDUCATION DAY, June 4 2014
17
Successful execution depends on
Detailed project plan
Clear designation of organizational roles and
responsibilities
Internal resources (cross functional team
members, project lead, regulatory lead etc.)
External resources (consultants, CRO, Advisory
committee, Attorneys, Health Authorities)
Effective support systems and procedures
Effective communication and decision making
18. Elements of Successful Regulatory Submission
Elements
of
successful
Regulatory
submission
Close interaction
with project
team and
following project
plans through
out development
process
Generation of
submission ready
documents in
conjunction with
completion of
development
activities
Creation of one
page registration
plan with defined
contact points with
concerned health
authorities
Creation of
regulatory strategy
to align regulatory
activities with
Business objectives
Application of
applicable
guidelines
throughout the
development
process
Use of standard
templates for
document creation,
review and
tracking
18 CAPRA EDUCATION DAY, June 4 2014
19. Close Interaction with Project Team
Purpose
To inform and be informed of all project/program level
developments with respect to project timelines
To identify, discuss, strategize on project/product specific
development issues
To discuss and decide on the ongoing development pathway
To develop internal and external communication strategy
Elements
Project Plans (timing)
Project Charter (project deliverables)
Budget/Resource requirements and constraints
19 CAPRA EDUCATION DAY, June 4 2014
Close interaction
with project team
and following
project plans
through out
development
process
20. Close Interaction with Project Team
Project Plans
Detailed, Integrated
Identifies key activities, resources, timing
Helps to define implement and control project
Gantt charts and project management software are useful
Started early
Communicated
Re-visited and revised as often as necessary
20 CAPRA EDUCATION DAY, June 4 2014
Close interaction
with project team
and following
project plans
through out
development
process
21. CAPRA EDUCATION DAY, June 4 2014
21
Have the target clinical indication and anticipated labeling claims for your product been
outlined as part of a preliminary target product profile?
Does your current program include consideration of anticipated future approval
requirements, e.g., endpoints, comparators, effect sizes, statistical criteria, based on
current approval precedents and ongoing competing clinical programs?
Does your program include consideration of a changing regulatory environment,
including implementation of new legislation, guidances, or review requirements?
Does your program proactively identify challenges or issues that may delay clinical
development and also define innovative solutions/approaches to circumvent these
challenges?
Does your program leverage newly accepted development tools to reduce clinical
development time and expense and also proactively plan to maximize acceptance of
foreign data to access global markets?
Does you program currently identify key opportunities to engage global regulatory
authorities and specify key data requirements to support these interactions?
Does your program proactively eliminate development risk and uncertainty, while
maximizing the potential for commercial success?
Interaction with Project Team
– Questions to Consider Close interaction
with project team
and following
project plans
through out
development process
22. Elements of Successful Regulatory Submission
Elements
of
successful
Regulatory
submission
Close interaction
with project team
and following
project plans
through out
development
process
Generation of
submission ready
documents in
conjunction with
completion of
development
activities
Creation of one
page registration
plan with defined
contact points with
concerned health
authorities
Creation of
regulatory strategy
to align regulatory
activities with
Business objectives
Application of
applicable
guidelines
throughout the
development
process Use of
standard
templates for
document
creation,
review and
tracking
22 CAPRA EDUCATION DAY, June 4 2014
23. Document Standards and Practices
Document Mapping
Creation of document maps for the specific submission
(e.g. CTA/ IND (Phase I, II, III), CTD (Module 2-5)
List of all documents categorized by sections of the submission under
consideration
Identification of source, summary and support documents
Use of standard formats and templates
Develop standard format, word style guide conventions to be used
for regulatory submissions
Communicate and train the project team members, authors, subject
matter experts (SME)
Develop templates for all required sections of the intended
submission for clarity, completeness, standardization and
compliance with the requirements
23 CAPRA EDUCATION DAY, June 4 2014
Use of standard
templates for
document
creation, review
and tracking
24. Document Standards and Practices
Review flows and timelines
Creation and communication of review flows, expectations and
timelines
Where will the document to review reside? Who will review
(internal/external reviewers), in what order and how long?
Tracking
Use of document maps for tracking of the documents in
planning, draft, review, completed
Tracking of document progress in relation to the submission
requirements and project plans
Communication to the project team for the status update
24 CAPRA EDUCATION DAY, June 4 2014
Use of standard
templates for
document
creation, review
and tracking
25. Elements of Successful Regulatory Submission
Elements
of
successful
Regulatory
submission
Close interaction
with project team
and following
project plans
through out
development
process
Generation of
submission ready
documents in
conjunction with
completion of
development
activities
Creation of one
page registration
plan with defined
contact points with
concerned health
authorities
Creation of
regulatory strategy
to align regulatory
activities with
Business objectives
Application of
applicable
guidelines
throughout the
development
process
Use of standard
templates for
document creation,
review and
tracking
25 CAPRA EDUCATION DAY, June 4 2014
26. Application of Guidelines
Purpose
Significant streamlining in application processes
Increased focus on effective and targeted compliance
activities
More consistent application of strong but
proportionate enforcement activities
26 CAPRA EDUCATION DAY, June 4 2014
Application of
applicable
guidelines
throughout the
development
process
27. Application of Guidelines
Know and understand the regulatory framework and
environment
Find all applicable guidelines
Global (ICH), Key/critical/important, regional/national
Share and communicate the key consideration(s) to the project team
Core to development
Get involved and Start early – right first time
Retrospective fix-ups take longer (time/cost/resource implications)
Keep an eye out for the new regulations, directives/
legislations/ guidance
Be active and get involved in providing comments to the draft
guidelines
Key to successful submission, review and outcome
27 CAPRA EDUCATION DAY, June 4 2014
Application of
applicable
guidelines
throughout the
development
process
28. Elements of Successful Regulatory Submission
Elements
of
successful
Regulatory
submission
Close interaction
with project team
and following
project plans
through out
development
process
Generation of
submission ready
documents in
conjunction with
completion of
development
activities
Creation of one
page registration
plan with defined
contact points with
concerned health
authorities
Creation of
regulatory strategy
to align regulatory
activities with
Business objectives
Application of
applicable
guidelines
throughout the
development
process
Use of standard
templates for
document creation,
review and
tracking
28 CAPRA EDUCATION DAY, June 4 2014
29. Generation of Submission Ready Documents
29 CAPRA EDUCATION DAY, June 4 2014
Generation of
submission
ready documents
in conjunction
with completion
of development
activities
30. Generation of Submission Ready Documents
Global regulatory strategy does not mean identical
processes or documentation
Obtain and manage documents during development
Critical for timely application of guidelines/unique
or national requirements during development
Important for introduction of standard practices for
document generation, review and tracking
Key to successful submission, review and outcome
30 CAPRA EDUCATION DAY, June 4 2014
Generation of
submission
ready documents
in conjunction
with completion
of development
activities
31. Regulatory Submissions
Simplistic Success Formula
CAPRA EDUCATION DAY, June 4 2014
31
Know the regulations, guidelines and specific
requirements
Develop quality data using appropriate GMP, GCP,
GLP, QSR and QbD requirements
Have well trained staff at all levels
Build and maintain strong communication links with
the regulatory authority before and during the review
process
Submit a well written dossier
Plan for all post-approval commitments