Programme Day One

Opening remarks from the Chairperson

Analysing 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

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 characterise 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

Incorporating risk minimisation strategies into your RMP and monitoring and evaluating the effectiveness of these risk minimisation 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 identified risk occurring with your pharmaceutical products and to keep these risks within certain thresholds; Identifying the adequate risk minimisation activities that can be employed as part of a holistic risk management plan
• Taking an in depth look at the regulation and proposed criteria surrounding risk minimisation activities
• Addressing the Importance of evaluating the effectiveness of additional risk minimisation activities in a timely defined manner  
• Realising 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 minimisation methods

Investigational medicinal products for the EU: rules, regulations, solutions and support

• 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
• Utilising 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 minimise 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

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 minimise 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 minimisation 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 minimisation 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?
• Recognising 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 marketing authorisation or one that displays a new safety concern?
• Understanding the role of signal detection to maximise your risk management and minimisation efforts
• Adopting formal signalling methodologies that incorporate all relevant internal and external data sources in order to capture and truly understand the benefir-risk ratio of a product

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
• Optimising your safety signal detection reporting by perfecting methods and best practices for prioritisation, analysis and documentation of safety signals
• Analysing 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

Moving from paper based to systematic signalling; 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 organisation from paper based signaling to systematic signalling

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
• Establishing different methodologies for signal detection for new medicines versus established medicines
• Outlining the tools that the MHRA apply for signal detection and the methods for analysing and prioritising signals
• Exploring the actions taken by the MHRA when various signals arise

Moving from reactive dependence on voluntary reporting of safety concerns to proactive surveillance of medical products in the market; Utilising observational studies and Sentinel/EU-ADR 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

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 optimise 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