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- Analyzing the latest developments in EU PV legislation; ensuring that your strategies are fully compliant and promote patient safety
- Addressing the challenges that future pharmacovigilance legislation may bring and ensuring that your pharmacovigilance strategies are fully compliant
- Examining the latest developments in the EU Commission’s pharmacovigilance package, ICH E2 guidelines and Volume 9A and understanding how best to tackle forthcoming amendments to legislation
- Clarifying the respective roles and responsibilities of all stakeholders involved in pharmacovigilance to ensure effective communication between NCA’s and EMEA
- Identifying the specific rules and regulations pertaining to pharmacovigilance data exchange and promoting transparency between all stakeholders involved
- Establishing clear standards for the conduct of pharmacovigilance by both the industry and the regulators in order to ensure Good Vigilance Practices
- Freeing up resources by rationalising and simplifying the reporting of suspected adverse drug reactions (ADRs)
- - expedited reporting - periodic reporting
- Ingebjorg Buajordet, Senior Adviser, Norwegian Medicines Agency
- Designing and implementing a robust, comprehensive risk management plan to achieve compliance with EU risk management requirements
- Reviewing the local regulatory environment and expectations of authorities in order to highlight the key elements to include in your RMP
- Considering and ascertaining the key factors in compiling and writing an accurate and practical risk management plan
- Evaluating pharmacovigilance activities and interventions that can be designed to identify and characterize the risks related to your pharmaceutical products
- Selecting the right tools to gather data that will enhance and improve the quality and depth of your risk management plan
- Ensuring effective risk management throughout the full product lifecycle; executing a fully integrated risk management plan that incorporates developmental safety data, robust clinical data and epidemiological data combined with post market surveillance to ensure product safety
- Involving the entire company including affiliates in your risk management strategy to gain buy in and understanding from the commercial departments
- Michael Forstner, Integrated Safety Risk Manager, Roche
- Incorporating risk minimization strategies into your RMP and monitoring and evaluating the effectiveness of these risk minimization initiatives to ensure that your risk measures are executed as planned
- Providing a detailed description of proactive measures taken by your company to reduce the probability of an adverse reaction occurring with your pharmaceutical products and to keep these risks within certain thresholds; Identifying the risk minimization tactics that can be employed as part of a holistic risk management plan
- Managing the risks that you’ve identified with your product and minimizing these risks by providing suitable training programmes, educational material, and letters to ensure that appropriate information on all aspects of your drug’s safety profile have been relayed to both health professionals and patients
- Taking an in depth look at the regulation and proposed criteria surrounding risk minimization tactics to leverage the tools and strategies available for a proactive risk minimization strategy
- Considering the specific tools available to evaluate whether your risk management plan and risk minimization tactics are proving effective; can initiatives such as patient focus groups aid in monitoring the effectiveness of your risk management strategy?
- Realizing that an efficient fully operational risk management strategy requires appropriate allocation of resources; Ensuring that sufficient time and energy is spent on continual monitoring of the effectiveness of your risk minimization methods
- Dr Yasmine Boulkroun, EU Risk Management Plans Coordinator, Global Pharmacovigilance and Epidemiology Europe, Cephalon
- Reviewing the FDA’s Risk Evaluation and Mitigation Strategies (REMS) legislation; developing and establishing appropriate risk measures to comply with the US market
- Assessing the legislation around REMS to clarify the strategies that can be implemented to produce a detailed and robust REMS document
- Designing a successful REMS program through the formation of an internal, cross-functional team including guidance from regulatory, drug safety, pharmacovigilance, clinical development, and marketing to operate the process
- Utilizing a replicable, science-based approach that identifies all the various risks of the drug in the care delivery process; elevating the outcome of your planning process from being one which is opinion based to one which is science based and therefore inviting a science based response
- Initiating the REMS planning process early and considering various issues that could occur late in the approval process and planning what to do in the event that they do; incorporating contingency planning into your REMS plan to minimize any potential delays on approval of your product by the FDA
- Ensuring that your REMS has been designed and programmed in a way that clinicians perceive as practical, useful and enhancing patient safety to increase the willingness of a physician to prescribe that particular drug
- Clarifying the opportunities to integrate various global risk management plans to create a global drug safety strategy; Best practice guidelines
- Dr Seema Jaitly, VP Global Medical and Scientific Affairs, Stiefel Laboratories, GSK
- Strengthening transparency and communication around benefit-risk and drug safety to increase the understanding of patients and health professionals and extend the reach of key warnings on drugs
- Understanding the need for better approaches to assessing the benefit and risk of medicinal products to ensure that the correct information can be relayed to health care professionals and patients alike
- Communicating safety and comparative benefit-risk to patients and the prescribing physicians; identifying the correct tools to ensure that safety information is being relayed effectively to the consumer
- Assessing the role of the worldwide web in communicating safety information on products to patients and prescribers; in an environment dominated by technology are websites the correct way forward in providing information to patients and prescribers?
- Evaluating how patients and prescribing physicians are taking decisions on comparative benefit-risk in order to understand the impact that your risk management plan has on both the likelihood of a physician prescribing a certain drug and a patient taking a certain drug
- Encouraging users to discuss any perceived undesirable side effects with their doctor or pharmacist to ensure that information on the safety profile of the drug is kept up to date
- Improving communication with health professionals, patients and the public to increase the accuracy of post marketing safety data
- Encouraging the public to report adverse reactions through increased communication to minimize under reporting
- Assessing PV reporting methods used by physicians and patients to establish clear and concise approaches to your PV strategy
- Panel session: Examining and sharing best practice to overcome the challenge of preparing robust pharmacovigilance risk management and risk minimization plans
- Assessing current complexities and controversies in pharmacovigilance and risk management throughout all phases of development and marketed use
- Exploring optimal strategies for risk assessment; case examples of risk assessment and minimization methods and the challenges that industry faces in performing high-quality risk management in a global environment
- Understanding the additional complexities and requirements when identifying risk for generics and biosimilars; what additional considerations should be made for these products if any?
- Recognizing additional factors that need to be taken into consideration when producing a risk management plan for a product that is already on the market; how do you design a risk management plan for a marketed product that may have undergone a significant change in marketingauthorisation or one that displays a new safety concern?
- Understanding the role of signal detection to maximize your risk management and minimization efforts
- Adopting formal signaling methodologies that incorporate all relevant internal and external data sources in order to capture and truly understand the benefit-risk ratio of a product
- Michael Forstner, Integrated Safety Risk Manager, Roche
- Dr Yasmine Boulkroun, EU Risk Management Plans Coordinator, Cephalon
- Dr Sandip Chaudhuri, Director Safety and Risk Management Lead, PFIZER
- Identifying best practice for the collection and reporting of safety data
- Developing robust signal detection methods and processes to identify adverse drug reactions (ADRs)
- Successfully executing signal detection during post market surveillance to facilitate the identification of possible adverse events and safeguard patient safety
- Meeting regulatory requirements and recent developments for signal detection and adverse event reporting
- Optimizing your safety signal detection reporting by perfecting methods and best practices for prioritization, analysis and documentation of safety signals
- Analyzing developments in datamining techniques and considering the use of qualitative versus quantitative signal detection methods
- Conducting effective statistical analysis in order to identify potential adverse events early
- Exploring CIOMS VIII and points to consider in the application of signal detection and signal management in pharmacovigilance
- Dr Sandip Chaudhuri, Director Safety and Risk Management Lead, Pfizer
- Moving from paper based to systematic signaling; ensuring readiness for the changes that CIOMS VIII will bring
- Outlining the current methodologies used for signal detection and the challenges that these bring
- Reviewing the current regulatory requirements around signal detection and CIOMS VIII guidance; what do we currently know?
- Assessing the gap between current methodologies, regulatory requirements and CIOMS VIII to ensure streamlined approaches
- Effectively making the transition in your organization from paper based signaling to systematic signaling
- Dr Karen Jaffe, Director Product Strategy, Oracle
- Tools for signal detection - a regulatory perspective
- Assessing the different sources for collecting signals to enable construction of a robust safety profile for a drug
- Managing data effectively to support proficient signal detection
- Reviewing the different procedures for signal detection between new medicines and established medicines to ensure quality in both processes
- Outlining the tools that the MHRA apply for signal detection and the methods for analysing and prioritizing signals
- Dr Shelley Gandhi, Unit Manager-Signal Management Group
- Vigilance & Risk Management of Medicines, MHRA
- Moving from reactive dependence on voluntary reporting of safety concerns to proactive surveillance of medical products in the market; Utilizing observational studies and Sentinel/EUADR projects for reporting of adverse events
- Building and implementing a surveillance system for actively querying diverse automated healthcare data holders—like electronic health record systems, administrative and insurance claims databases, and registries—to evaluate possible medical product safety issues quickly and securely
- Leveraging observational data from healthcare data to look for safety signals associated with marketed products and help augment spontaneous reporting of safety signals and adverse events
- Establishing privacy and security safeguards so that data continues to be managed by its owners to ensure that data protection laws are complied with
- Dr James Higginson, Safety Surveillance Adviser, Novo Nordisk
- Ensuring companywide readiness for pharmacovigilance audits and inspections
- Proactively preparing and coordinating for risk based inspections to meet regulatory requirements
- Ensuring that the documentation regarding your pharmacovigilance systems is kept up to date at all times in order to pre-empt unexpected inspections
- Making full use of resources and metrics available to you to optimize the outcomes of your inspections Instilling an ownership mindset throughout your team in order to
- promote successful inspection results
- Responding effectively to the changes and recommendations outlined by the authorities with regards to your pharmacovigilance systems
- Dr Franck Schwartz, Senior Director, Safety and Compliance, IPSEN
- The regulatory landscape; addressing the changes in future EU legislation from an industry perspective
- Highlighting what the future may bring for pharmacovigilance legislation and the impact this will have on drug safety professional in the industry
- Evaluating whether we will get more or less value for money when it comes to product safety
- Europe's pharmacovigilance package - guidance on the legislative proposals designed to simplify rules and procedures and to improve patient safety through better monitoring and providing them with a central source of safety information; From vision to reality
- Outlining and understanding the draft update of the Notice to Applicants Volume 10 on ‘Handling of Safety Data in Clinical Trials (CT-3)
- Gro Laier, Deputy QPPV, International Product Safety, Novo Nordisk
- Evaluating the role of outsourcing in the pharmacovigilance industry
- Establishing a robust, cost effective outsourcing strategy that will enhance your pharmacovigilance and risk management strategy
- Understanding the prospects that outsourcing can provide to meet the increasingly complex and constantly changing worldwide regulations for pharmacovigilance
- -higher levels of inter-disciplinary expertise
- -demands to improve public safety
- Deciding which aspects of your pharmacovigilance system can be outsourced to reduce fixed overhead costs, avoid high upfront investments, secure additional capacity and increase resource flexibility
- Ascertaining whether your outsourcing partners have sufficient processes and procedures in place and qualified staff to handle the entire pharmacovigilance process
- Maintaining oversight of your outsourced pharmacovigilance functions to ensure that the quality and compliance standards required by the authorities are still met, including EU QPPV oversight as required by Volume 9A
- Dr Peter de Veene, Deputy QPPV, Roche
- Panel session: Analyzing the opportunities and challenges for offshoring of your pharmacovigilance systems and processes
- Considering the benefits of outsourcing to lower cost countries such as India and Hungary to reduce your labor costs
- Assessing the specific challenges that arise when off shoring; how can you overcome challenges such as language barriers and transparency issues?
- Ensuring that offshoring partners have a full understanding of your PV processes and needs in terms of quality and compliance to meet regulatory requirements
- Maintaining full oversight of all offshored pharmacovigilance activities to ensure a robust, validated pharmacovigilance system capable of meeting all your in-house requirements
- Dr Peter de Veene, Deputy QPPV, Roche Aileen Stuart, Senior Director, Safety Operations,
- Johnson & Johnson
- Ensuring optimal understanding and organization of your safety documentation
- Understanding how to handle submissions of a Detailed Description of Pharmacovigilance Systems (DDPS) in order to comply with pharmacovigilance regulatory obligations
- Comprehending what the PV legislation requirements are in relation to the Detailed Description of Pharmacovigilance Systems: What are the regulators looking for?
- Examining the depth and level of information required in order to compile a succinct and precise DDPS
- Optimizing the collection of safety data, the preparation of aggregate reports and other process requirements in order to accurately reflect these on your DDPS
- Planning effectively to ensure that you meet the challenging deadlines associated with the submission of DDPS
- Addressing the challenge of aligning the DDPS as contemporaneous MAAs are being submitted and evaluated
- Allocating your human resources effectively to meet the high workload demands of DDPS submissions
- Dr Izabella Bossowska, EU Qualified Person for Pharmacovigilance, Allergan
- Examining the complex role of the PSU R in the pharmaceutical risk management process in order to avoid the submission of incomplete PSU Rs
- Conducting systematic, effective analyses of safety data on a regular basis in order to submit an accurate description of the safety profile of drugs in your PSURs
- Planning PSURs effectively to ensure you are in a position to protect the public
- Understanding how the PSUR provides a vehicle to managing corporate risk and that an inappropriate analyses of the findings may result in the market loss of valuable new drugs after massive research and development investments
- Reporting alleged side effects associated with administration of a drug to meet regulatory demand
- Considering signal detection and signal analysis outcomes and reflecting these on your PSURs to enhance the information provided on the drug safety profile
- Providing a consistent, broad based examination of the information on an active substance utilizing a single data lock point to gain a clear benefit -risk profile for a drug substance that may have many uses and many user profiles
- Dr Marina Belle, Drug Safety and Pharmacovigilance Manager, Aggregate Reports, Sandoz International
- Utilizing the Development Safety Update Report (DSUR) to achieve effective and efficient risk communication
- Implementing standardized Development Safety Update Reports to reduce duplicate periodic reporting to the US and EU by sponsors during development programmes
- Analyzing the specific requirements of the future DSUR and considering their role in effective risk communication
- Initiating a single, integrated life cycle periodic safety report covering both development and post marketing to reduce the work burden of maintaining separate PSURs and DSURs which can overlap considerably in content
- Pilar Carrero, Manager, Safety Medical Writing, Novo Nordisk
- Strengthening your pharmacovigilance processes and systems to protect public health
- Forging stronger relationships between pharmacovigilance and manufacturing to increase the data available for assessing the benefit-risk ratio of drugs
- Analyzing the data collected surrounding drugs at the manufacturing stage to ensure that technical errors in production do not impact on pharmacovigilance and risk assessment further down stream
- Considering optimal strategies for maintaining, optimizing and reinforcing a strong link between manufacturing and pharmacovigilance units to facilitate exchange of data
- Evaluating your drug manufacturing processes to address the potential influence these may have on pharmaceutical quality and composition and ultimately drug safety
- Dr Agnieszka Majcher Dann Acting QPPV Consumer, Johnson & Johnson
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