DAY TWO | WEDNESDAY, OCTOBER 30
7:30 REGISTRATION & WELCOME COFFEE
8:00 CHAIRPERSON’S OPENING REMARKS
Klaas Van’t Klooster, Clinical Manager, JOHNSON & JOHNSON
8:15 CASE STUDY: OVERCOMING OBSTACLES IN DESIGNING MDR-COMPLIANT POST-MARKET CLINICAL TRIALS
- Exploring factors to determine endpoints for post-market clinical studies
- Managing translation of pre-market studies to the post-market phase
- Adapting to indefinite timelines
- Location considerations
- Budgetary needs
- Special considerations in structuring new MDR-compliant PMCF trials
Andreas Gmerek, Senior Manager Medical Scientific Affairs, B. BRAUN AVITUM AG
8:45 CONTINUOUS PHYSICIAN OVERSIGHT TO ENSURE RAPID COLLECTION OF HIGH-QUALITY POST-MARKET DATA
With healthcare professionals’ unique position to actively collect product safety and efficacy evidence in the real world setting, clinical affairs teams aim to establish strong relationships with hospital teams as well as robust training geared toward data needs. However, the industry often faces complications with decreasing physician interest and motivation over time in post-market research, as well as with non-compliant practices such as deviations from authorized use. It is therefore incumbent upon the company to motivate the physician to partake in a win-win relationship through carefully-planned communication regarding the mutual goal of device success and improvement, ultimately supporting positive patient outcomes.
Michal Slomczykowski, Medical Director, GEISTLICH PHARMA AG
9:15 UPDATES TO GOOD CLINICAL PRACTICE STANDARD: ISO14155 REVISION PROCESS
- Sharing practical insights into the ISO14155 revision process
- Highlighting differences between the current 2011 and expected revision (2020 version)
- Next steps for industry in the application of the new standard
Klaas Van’t Klooster, Clinical Manager, JOHNSON & JOHNSON
9:45 COFFEE & NETWORKING BREAK
10:15 COLLECTING CLINICAL EVIDENCE IN A POST-MARKET SETTING: THREE SUCCESS STORIES
Planning and executing a successful post-market clinical data collection strategy is a challenge, and the lack of examples of how PMCF studies shall be conducted leaves many uneasy. The requirements for clinical evidence vary depending on the device type and classification, but “proactive” remains a keyword within the regulation. This presentation focuses on three different cases of PMCF studies, based on real use cases from manufacturers that have had success with proactive data collection. The goal is to inspire other manufacturers, and provide guidance for implementing a successful post-market data collection strategy under the MDR.
Jón I. Bergsteinsson, Co-Founder and VP of Global BD, SMART-TRIAL
POST-MARKET STRATEGIES & TEAM STRUCTURES ENSURING A COMPREHENSIVE APPROACH TO ENHANCED REQUIREMENTS
Within the new post-market regulatory environment including different concepts and tasks such as PMCF, PMS, PSUR and CER, clinical research teams must be structured so as to effectively combine data sets and optimize the use of internal resources. Confusion currently lies in how to correctly handle one task before the next, in order to ultimately generate and report product safety and efficacy evidence, as well as to package data from different sources efficiently. Team structuring alongside clear defining of the differences and overlap of each operation are key to the compliant management of necessary post-market duties on time and within budget.
11:00 PART 1: LARGE COMPANY PERSPECTIVE
Paola Vivoda, Head of Clinical Operations, EMEA, ZIMMER BIOMET
11:30 PART 2: MIDSIZED COMPANY PERSPECTIVE
Kemine Hale, Senior Manager Regulatory & Clinical Affairs, ADVANCED BIONICS
12:00 CASE STUDY: PRACTICAL CONSIDERATIONS IN ESTABLISHING INDUSTRY-SPONSORED REGISTRIES
- Timing & processes for cost-effective structure
- Cost considerations in industry-led registries
- Determining true value of potential insight
- Incorporating data cleaning costs into plan
- Ethics committee approval & location selection
Melanie Crystal, Senior Clinical Program Manager, MEDTRONIC
12:30 LUNCHEON FOR ALL PARTICIPANTS
1:30 MAXIMIZING REGISTRY DATA: RELEVANCE, ACCESS & ACCEPTABLE USAGE
As clinical research executives increasingly consider registries as a cost-effective tool to obtain relevant real-world clinical follow-up material, uncertainties persist regarding the degree to which registry data will be considered acceptable by notified bodies and competent authorities. Additionally, divergent interpretations surrounding whether registries should be industry-sponsored, as well as the nature of data that can be gathered compliantly, have led to further need for clarification. Industry members seek simplified and practical insight into compliantly structuring registry studies enabling the collection of relevant information useful to achieve post-market evidence goals.
Norbert Clemens, Senior Manager Science & Clinical Affairs/DPO
KANEKA PHARMA EUROPE N.V.
2:15 ENHANCING THE USE OF DEVICE DATA GENERATED BY HOSPITALS IN POST-MARKET STRATEGIES
Given the importance of real-world evidence within the framework of MDR, medical device companies are considering device performance data from hospitals as a potential source of valuable information. However, hospital data sets often require resource-intensive cleaning to extract relevant evidence, and limitations instated by GDPR further call into question the viability of the information to meet regulatory demands. Clinical executives are therefore pursuing practical knowledge on successful methods to establish data-driven collaborations with hospitals and compliantly integrate hospital-generated device performance data into PMCF plans.
- Identifying relevant & acceptable hospital information
- Opportunities in data collection partnerships with hospitals
- Cost considerations & ensuring compliance with GDPR
- Appropriately positioning hospital data in the PMCF plan
Ruben Roijers, Manager, Q&R – Post-Market Surveillance, PHILIPS HEALTHCARE
3:00 COFFEE & NETWORKING BREAK
3:30 EXCHANGE GROUPS: COMPARING STRATEGIES TO ENSURE GDPR COMPLIANCE IN PMCF DATA COLLECTION
GDPR has opened new challenges for clinical research professionals seeking to obtain post-market clinical evidence from external sources, with many data sets inaccessible due to privacy concerns. Careful consideration must therefore be given to the ownership of information from individual registries, surveys, and other sources in order to proactively guard against investment in data sets that may lead to privacy infringement. Through an engaging peer-to-peer discussion, audience members will have the opportunity to share experiences and best practices in obtaining relevant evidence generated outside of traditional clinical studies, all while remaining compliant with GDPR provisions.
Lincoln Tsang, Partner, ARNOLD & PORTER
4:00 OPTIMIZING PATIENT SURVEYS FOR PMCF DATA COLLECTION: FOCUS ON DESIGN, RELIABILITY, AND PRESENTATION OF RESULTS
As clinical research professionals endeavor to provide a well-rounded body of evidence to notified bodies regarding the safety and efficacy of medical devices on the market, many in the industry seek insight into best practices for the use of survey data. While patient surveys are rich in qualitative feedback, challenges reside in extricating complaint information from the responses, as well as in identifying data sufficiently specific to meet authorities’ expectations while remaining compliant with privacy standards. In order to ensure the highest level of efficacy and safety evidence, the structure of the survey as well as a thoughtful strategy to analyze and utilize results must be carefully considered.
- Considering the relative value of survey data in PMCF
- Survey structure enabling the collection of targeted data
- Disentangling complaints information from survey data
- Optimizing extraction & use of anonymous survey data
Elizabeth Weathers, Clinical Research Manager, IBA GROUP
4:30 CLOSING REMARKS & CONFERENCE CONCLUSION