Programme Day Two

Assessing the role of social media and web based ADR reporting in pharmacovigilance

Evaluating the vital role that epidemiology plays as part of a comprehensive drug safety strategy

Overcoming the challenge of completing the Detailed Description of Pharmacovigilance Systems (DDPS) report for regulatory compliance

Optimising pharmacovigilance surveillance and risk mitigation on ‘off-label’ use drugs

Exploring the pharmacovigilance regulation and best practice associated with ‘named patient’ drugs which have been prescribed on compassionate grounds

Implementing and evaluating risk management and risk minimisation measures as part of a holistic pharmacovigilance strategy

The regulatory landscape; addressing the changes in future EU legislation from an industry persepctive

• Highlighting what the future may bring for pharmacovigilance legislation and the impact this will have on drug safety professionals 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)

Establishing a robust, cost effective outsourcing strategy that will enhance your pharmacovigilance strategy 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

Panel session: Analysing 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 labour costs
• Assessing the specific challenges that arise when offshoring; 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 off shored pharmacovigilance activities to ensure a robust, validated pharmacovigilance system capable of meeting all your in-house requirements

Round table debrief: Executive summaries of the roundtable discussions

In this session, each roundtable facilitator will have 5 minutes to present the findings and provide a summation of the top line themes, challenges and solutions to come out of the roundtable discussions which took place in the morning   

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
• Optimising 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

Utilising the Development Safety Update Report (DSUR) to achieve effective and efficient risk communication

• mplementing standardised Development Safety Update Reports to reduce duplicate periodic reporting to the US and EU by sponsors during development programmes
• Analysing 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

Examining the complex role of the PSUR in the pharmaceutical risk management process in order to avoid the submission of incomplete PSURs

• 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, broadbased examination of the information on an active substance utilising 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

Forging stronger relationships between pharmacovigilance and manufacturing to increase the data available for assessing the benefit-risk ratio of drugs

• Analysing 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, optimising 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