Pharmacovigiliance

DAY 1, plenary

Keynote presentation:

Enhancing cross-functional communication in order to soften the practical implications of the new European pharmacovigilance legislation on the industry

• Contextualizing the biggest change the industry has seen since the initiation of EMA in an attempt to take stock of the current state of drug safety
• Outlining the challenges of having to implement significant changes without the availability of an application modality
• Uncovering country-specific differences in the EU guidance documents in a strive for true harmonisation
• Discovering practical methods to efficiently share information between the clinical and post-marketing departments to compile a complete set of signals
• Removing operational roadblocks to efficient information-sharing between clinical and post-marketing to simplify PV oversight and create superior safety profiles

Heiko Martin, Head of Global Drug Safety, Grunenthal

Evaluating the workload associated with the new EU reporting requirements to achieve a seamless transition

• Examining crucial developments and analysing the current state of the EU pharmacovigilance legislation to effectively evaluate their immediate impact on the industry
• Modifying your E2B system to include electronic rules to efficiently capture non-serious events
• Devising reliable compliance metrics around reporting assays to prove the timely reporting of non-serious cases
• Unveiling the official regulatory format and content of PSURs and RMPs to avoid time-consuming surprises
• Optimising transparency and communication through public hearings, coordination of safety announcements and web portals for a successful Industry/regulator partnership
• Establishing intelligent shortcuts of case distribution to affiliate partners for a efficient and timely reporting process
• Delineating future obligations following the launch of a fully functional EudraVigilance database to take full advantage of a central safety database
• Clarifying the reporting requirements of rare cases to alleviate insecurities and avoid serious reporting mistakes

Doris Stenver, CMO, Danosh Medicines Agency - Pharmacovigilance Working Party, EMA

Unveiling the practical implications of the new ICH Individual Case Safety Report (ICSR) standard

• Outlining the key aspects and main principles of the ICH Individual Case Safety Report (ICSR) standard to enhance the industry’s understanding of imminent changes in reporting requirements
• Analysing the ICH follow-up standard E2B(R3) to clarify future implementation procedures
• Recognising the territory-dependent differences in reporting requirements to reduce compliance issues
• Understanding the impact of the ICH M5 (IDMP) standard on ICSR reporting

Alastair Fowkes, Associate Director, Processes & Standards, AstraZeneca - EFPIA Deputy Topic Leader for the ICH E2B Expert Working Group

Case study: Measuring the effectiveness of Risk Management Plans in practice - recent example from Roche

• Scrutinising the objectives of a Risk Management Plan and exploring tactics for changing behaviours of doctors and patients
• Dismissing current tools for communicating safety risk and their mitigation to physician and patients to overcome one of the major remaining challenges in pharmacovigilance
• Developing new methods and skills to effectively measuring the impact of mitigation tactics r
• Highlighting recent examples will at Roche, e.g. labelling and training material effectiveness and pregnancy prevention

Philippe Van der Auwera, MD, PhD - Global Head of Safety Risk Management , F.Hoffmann-La Roche

Rationalising how outsourcing pharmacovigilance activities can strengthen your regulatory compliance and immensely increase flexibility

• Elucidating strong reasons to outsource drug safety to considerably increase your flexibility
• Leveraging risks associated with outsourcing to take necessary precautions
• Revealing the risks and benefits of several outsourcing models to enable you to make the right choice for your business
• Focusing on key aspects of outsourcing pharmacovigilance to equip you with critical vendor management skills
• Scrutinising resource management and vendor training strategies to enhance efficiencies in pharmacovigilance
• Building a reliable and trustworthy partnership to guarantee inspection readiness
• Exploring risk-sharing techniques to instigate effective cost reductions

Sabine Richter, PhD, M.Sc, Vice President Safety and Risk Management, PRA International

Scrutinising best practices and benchmarks of implementing the new EU legislation

• Devising a clear set of industry-wide expectations in order to create an environment in which companies can work efficiently
• Examining how the agency and authorities can work with the industry to streamline processes
• Comparing implementation timelines and deciphering change management procedures for a full understanding of pending workload
• Understanding the implications of recording adverse events from indirect reports on data privacy and transparency
• Weighing out the benefits and disadvantaged of the legislation to strengthen pharmacivigilance activities
• Discovering how member states interpret distinct aspects of the legislation to adjust your new procedures to the authorities’ expectations
• Sharing experiences of implementation processes and learning how other have overcome obstacles and challenges while implementing the legislation

Katrien Soleme, Associate Director, Pharmacovigilance & Affiliates Quality Services, UCB Pharma

Susanna Palkonen, Executive Officer, EFA

Alastair Fowkes, Associate Director, Processes & Standards, AstraZeneca - EFPIA Deputy Topic Leader for the ICH E2B Expert Working Group Franck Schwartz, Senior Director, Safety and Compliance, Ipsen

STREAM A

Overcoming operational challenges of DSUR implementation for continuous improvement

• Devising best practices on how to incorporate an efficient DSUR workflow into your existing procedures to set an exemplary industry benchmark
• Establishing successful strategies to convert legacy data to the appropriate format for satisfactory DSUR completion
• Elucidating the extent of registry information you have to collect to satisfy regulatory requirements
• Constructing operational procedures for cross-functional and global information collection for a well-rounded DSUR
• Appointing a dedicated project team to optimise cross-functional lines of to yield sufficient safety information about your drug
• Providing examples of a well-structured DSUR to master second-generation implementation
• Uncovering effective ways to re-negotiate investigator contracts to simplify information collection from investigator-sponsored studies

Rachel Spokes, Senior Safety Scientist & EU Safety Manager, Allergan

Implementing technical procedures to automatically produce necessary data for your DSUR

• Explaining steps you must take for an efficient database upgrade to be compliant with the official DSUR deadline
• Analysing logistical challenges of updating databases to tight deadlines to optimise your preparations
• Generating an automatic links between databases that will enable the responsible person to pool all necessary data simultaneously, allowing more time for analysis
• Illustrating effective methods to modify data formats according to EMA requirements
• Compiling valuable input from medics to achieve goal-oriented results in interface programming

Astrid Herpers, Head of EU-QPPV office, EU-QPPV, Boehringer Ingelheim

Revealing exclusive regulatory impressions of early DSUR submissions to optimise your current DSUR process and reduce workload in the long run

• Highlighting common failings and analysing the detailed content of ideal submissions to reach a clear understanding of regulatory expectations
• Assessing the value of the information included in the DSUR to the authorities to strengthen industry confidence in the new legislation
• Elucidating the specific expectations of national authorities about DSUR implementation and submission to optimise drug safety activities in world-side clinical trials
• Identifying ways to mitigate region-specific requirements and streamline your DSUR submission process

Dr Kirsty Wydenbach, Medical Assessors, MHRA

STREAM B

Unveiling the scientific guidelines on PAES design to successfully yield reliable information on the efficacy of your drug

• Clarifying official guidelines, regulatory confinements and the organisational impact of conducting PAES
• Determining what specific information you aim to produce in order to design a fit-for-purpose post-authority efficacy study
• Generating elaborate templates to yield valuable data for your PSUR
• Leveraging the benefits of an enhanced registration package in saving costs and time
• Establishing realistic strategies to efficiently examine the comparative efficiency of your drug in the real world
• Determining the in-points of your efficacy study early on to simplify trial design and optimise the outcome

Sandip Chaudhuri, Director and Safety Risk Management Lead, Pfizer

Demonstrating qualitative and quantitative methods to successfully include an unrivalled risk-benefit assessment in your PSUR

• Assessing the findings and recommendations of the E2C working party to clarify the latest requirements for PSURs
• Defining operational procedures for efficient cross-referencing to swiftly align safety messages across all documents
• Evaluating the best available signal detection tools to create greater depth of data analysis and optimize your risk-benefit balance
• Shifting the industry’s mindset from data-dumping to result-driven evaluation to master the skills needed for an immaculate risk-benefit assessment
• Examining the viability of a dedicated PSUR department as a realistic resource-solution
• Discovering how to prove that your drug’s benefits outweigh its risks to develop a well-balanced description of your drug’s efficacy and safety
• Achieving consistency in medical coding as a pre-requisite for efficient analysis within PSUR

Michael Richardson, International Head GPV&E and EU QPPV, Bristol-Myers Squibb - member of the E2C working party

Mastering signal detection techniques in small companies to efficiently identify safety risks and protect public health

• Pinpointing key strategies to recognise real signals in a small number of cases
• Allocating stringent timelines for the aggregation and comparison of figures to minimise the risk of late cases
• Exploring the viability of contracting out signal detection activities to save resources and fully exploit your vendor’s expertise
• Adopting reliable mechanisms to collect unsolicited reports and efficiently track the safety of your product

Elizabeth Schuller, Head of Pharmacovigilance & Medical Information, Intercell

DAY 1, plenary

Discovering expert ways to efficiently track patient reports for enhanced drug safety

• Establishing a solid relationship with European authorities to quickly yield additional consumer information upon request
• Vigorously pursuing consumer reports for medical evaluation to optimise signal detection and simplify causality assessments
• Highlighting the FDA’s experience with direct consumer reports to achieve equal efficiency in Europe
• Devising effective strategies to assess consumer reports appropriately to maintain a healthy safety profile
• Learning how to tap into the EMA’s database and confidently separate valuable information from general noise for efficient safety signal identification

Dr Julia Appelskog, Nordic Drug Safety Manager, Johnson & Johnson

Analysing the complexities of the FDA final rule and drawing neat parallels to EU requirements to set the benchmark in regulatory compliance

• Examining to what extent the FDA final rule impacted current practices and caused significant revisions to internal procedures
• Devising pre-defined criteria for expediting events to the FDA based on the new guideline
• Developing clear guidelines for how frequently medics must review safety databases in order to expedite all serious cases in a timely manner
• Investigating the fastest methods to extract further information from sites to help determine the seriousness and causality of a case
• Generating solid decision criteria on expediting single cases to fully comply with the final rule

Franck Schwartz, Senior Director, Safety and Compliance, Ipsen

DAY 2

Keynote presentation:

Setting up intelligent monitoring procedures to utilise social media to your full advantage

• Adopting a cautious approach to social media-generated adverse events to avoid entering unreliable information into your database
• Raising cross-company awareness that social media might yield SAEs to avoid missing important clues concerning your drug
• Dedicating sufficient time to screening social media reports to strengthen your case for the authorities
• Exploring efficient strategies to confirm the validity of your data to avoid the dilution of your data and prevent duplications
• Analysing the source of reports to easily identify fraudulent reports and avoid skewing signal scores
• Increasing public information about your drug to maximise the validity of social media reports, eliminate bias and improve the quality and accuracy of consumer reports

Vicki Edwards, Senior Director, European Pharmacovigilance, Abbott

Striving for a regulatory framework that will facilitate appropriate monitoring of company sponsored and non-company sponsored websites to improve the monitoring of medicine safety

• Achieving best practice in the management of safety data from company sponsored websites.
• Collaboration to devise a regulatory framework that facilitates the use of data from non-company sponsored websites to complement traditional monitoring methodologies
• Assessing scientific approaches to aggregate analysis of online data to help generate or confirm potential signals
• Harnessing technological advances to tap into the high volume of near real-time internet data for improved product understanding

Esteban Herrero Martinez, Regulatory Manager, ABPI
Lisa Howell. Director Global Patient Safety, Eli Lilly - ABPI Pharmacovigilance Expert Network (PEN) representative

Encouraging critical thought and constructive feedback on how to handle reports produced by social media to create an industry-driven gold standard

• Should you expand the extent of your monitoring activity to such sites as facebook and twitter to gain new insights into your drug’s safety profile?
• Debating whether data sourced from social media is valuable for signal detection and testing the validity of the report
• Prompting regulators to take a stance and devise reporting requirements for data gathered from social media
• Clarifying what is allowed, ethically acceptable and morally abject when you come across adverse events reported on an unsponsored website
• Generating robust defence mechanisms against fraudulent media reports - how can you effectively protect your company’s reputation?
• Questioning the benefit of monitoring social media altogether to effectuate a shift in regulatory requirements

Gro Laier, Deputy QP International Product Safety, Novo Nordisk
Lisa Howell. Director Global Patient Safety, Eli Lilly - ABPI Pharmacovigilance Expert Network (PEN) representative
Shelley Gandhi, Unit Manager-Signal Management Group, MHRA

Revealing the most common inspection findings by the MPA following the recent change in EU legislation and discovering best preparation practices

• Delineating the MPA’s inspection practices and drawing parallels to other European authorities to be equally-well prepared for unexpected audits
• Assessing frequent deficiencies and clarifying the MPA’s classification of deficiencies from recent experiences
• Ensuring constant access to regulatory intelligence and fixing previous findings promptly to appease national authorities during inspections
• Exploring all sources of information, including regulatory literature, to identify all major and critical findings to optimize preparation procedures for inspection-naïve companies
• Analysing the definition of “main findings” that have to be contained within the master file to optimize its maintenance
• Unveiling effective corrective and preventative actions for the most common inspection findings
• Anticipating future developments in the regulatory landscape for drug safety

Anna Toth, Pharmacovigilance Assessor/Inspector, Medical Products Agency

Integrating post marketing signal detection, escalation and management into risk management for optimal results

• Expanding the net of safety data sources as generators of signals: the case of non valid reports, social media and patient support programmes
• Discovering the place of traditional and automated signal detection techniques to create greater depth of data analysis
• Critically assessing the cost-benefit ratio of outsourcing signal detection to keep risky decisions to a minimum

Philippe Close, CSO, Novartis

Discovering how to maintain a high degree of quality when deciding to outsource pharmacovigilance activities

• Defining the QPPV’s role in the decision-making process to outsource certain PV activities to safeguard integrity and accountability post-decision
• Gaining insight into vendor selection criteria based on the specific PV activity to drive decision-making and guarantee high quality of services
• Applying elements of your internal quality system to your outsourcing partner to accurately oversee performance
• Considering an optimal controlling through detailed design of the contracts and service level agreements
• Integrating the vendor into your processes and workflow and setting up a specific quality control systems for optimal results
• Scrutinising the advantages and disadvantages of outsourcing in general and to naive territories to optimise decision-making

Jutta Syha, Director Corporate Drug Safety Operations, Deputy EEA QPPV, Biotes