Agenda

Philadelphia, PA, 10 - 11 April 2018

Schedule

Create your personal agenda –check the favourite icon

Apr 1008:45
Conference pass

Producers remarks

Keynotes
Edward Glanville, Project Director, Terrapinn USA
Apr 1008:50
Conference pass

Chair's opening remarks

Keynotes
Susan Welsh, Chief Safety Officer, CSL Behring
Apr 1009:00
Conference pass

Safety is the new efficacy: defining the value of safety across the pharmaceutical industry

Keynotes
  • Death, Disability and Discomfort – analyzing the intersection of different value equations in drug safety 
  • Using the patient perspective to define a value framework
  • Developing a new generation of safety surveillance systems by leveraging forward-thinking technology 
Jose Vega, Chief Safety Officer, Merck & Co., Inc.
Apr 1009:20
Conference pass

The committee experience: How AbbVie is leveraging technologies and developing IND for every product as part of standard protocol

Keynotes
  • How AbbVie is driving the future of PV by implementing the schedule and technologies of tomorrow today 
  • Understanding the need to adopt new technologies in PV - what are the efforts behind implementation?  
  • How to partner with and develop a new generation of PV specialists 
Fabio Lievano, Vice President Safety Sciences, Medical Safety Evaluation, Abbvie Pharmaceuticals Inc
Apr 1009:40
Conference pass

Disruptive innovation in Pharmacovigilance: Exploring new analytical techniques and signal detection strategies to stay ahead of the curve

Keynotes
  • How new analytical techniques in PV have enabled us to delve deeper into signal management 
  • Implement or die: how do we use design thinking to enable the implementation of new technologies?
  • Collaboration is key: leveraging cloud computing, data sharing and signal detection methodologies to benefit the patient
Felix Arellano, Global Head Pharmacovigilance and Drug Safety, Roche
Apr 1010:00
Conference pass

SPONSORSHIP AVAILABLE

Keynotes
Do you have a solution you would like to share with our audience?
Contact Michael Shackil now on: michael.shackil@terrapinn.com or call at +1 646.619.1809
Apr 1011:30
Conference pass

Post-market safety reporting for combinational products: getting ready for July 2018

BigData & PV
  • Device meets drug – evaluating the necessary industry considerations 
  • Non-traditional approaches of engaging with the patient to maximize outreach
  • Leveraging existing Title 21 federal regulated processes and structures to stay compliant 
Moderator: Khaudeja Bano, Senior Medical Director, Abbott Diagnostics
Kirsten H. Paulson, Sr. Director Global CMC-Medical Devices, Pfizer
Mike Thomas, Medical Director Pharmacovigilance, United Therapeutics
Apr 1011:30
Conference pass

Increasing patient engagement & education to save the healthcare industry billions by incorporating game changing mobile technologies

NEXT GENERATION TECH IN PV
  • How poor patient compliance and adherence costs the healthcare system more than $564 billion annually 
  • Increasing patient adherence through game-changing mobile technologies such as patient portals and reporting apps 
  • Preventing adverse drug events with computerized physician order entry (CPOE) and clinical decision support (CDS)
Arvind Bellur, Director, Head of Safety Data Management, Sanofi
Apr 1011:30
Conference pass

CAR-T: Spearheading the launch of a new therapy class and utilizing IND CNC data to increase product safety

PATIENT CENTRIC PV
  • Predicting safety outcomes by profiling incoming apheresis characteristics 
  • How vector lot characteristics contribute to the final product 
  • New databases to monitor CAR T-Cell Safety Across INDs 
  • How the FDA would protect confidential information if the agency plans to share data from the pilot
  • Looking at cross-IND CMC data to identify steps in the manufacturing process that might significantly influence a product's safety 
David Chonzi, VP, Patient Safety and Risk Management, Gilead Sciences
Apr 1011:50
Conference pass

Automation in Pharmacovigilance data processing – Can you trust AI?

NEXT GENERATION TECH IN PV
  •  How AI automates repetitive and routine manual tasks such as adverse event case reporting 
  • Does AI reduce patient centric Pharmacovigilance or does it decrease time spent sifting through adverse events? 
  • Building AI into adverse event case processing to allow pharmacovigilance resources to be focused on strategic activities
  • Working smarter and faster with reliable data at your fingertips through automation of PV processes
Sundeep Sethi, Vice President, Safety Operations, AbbVie
Apr 1011:50
Conference pass

Analyzing the new ICH E19 guidelines on optimization of safety data collection: what are the implications for your organization?

PATIENT CENTRIC PV
  • Harmonized guidance on targeted approaches to safety data collection in late-stage pre- and post-marketing studies
  • How the guideline aims to improve global health by encouraging studies on long-term effects, rare events and new indications of drugs while optimizing resources 
  • Understanding the challenges in implementation of such a guideline
Jeremy Jokinen, Senior Director, Safety Decision Analytics, AbbVie
Apr 1012:10
Conference pass

SPONSORSHIP AVAILABLE

BigData & PV
Do you have a solution you would like to share with our audience?
Contact Michael Shackil now on: michael.shackil@terrapinn.com or call at +1 646.619.1809
Apr 1012:10
Conference pass

Automation is transforming pharmacovigilance. Is your organization ready?

PATIENT CENTRIC PV
  • Is AI hype or reality?
  • Do you have the organizational discipline to transform your organization?
  • How do you find appropriate opportunities in the space?
  • Steps involved in implementing a PV AI strategy
Vivek Ahuja, Vice President of Global Pharmacovigilance, Arisglobal Pvt Ltd
Apr 1012:30
Conference pass

ROUNDTABLES

Keynotes
1) SPONSORSHIP AVAILABLE
2) PV and Outsourcing - Understanding how to evaluate and implement sourcing alternatives for PV business processes and underlying technologies
Kostas Kidos, VP, Head Global Drug Safety Operations, Shire Pharmaceuticals
3) International regulation- Understanding the current regulatory landscape
Armughan (Armie) Khan, Associate Director, PV Compliance & Interim Deputy QPPV, Kite, A Gilead Company
Mehul Patel, Kite, A Gilead Company
Elena Yureneva, Principal Scientist, Clinical Safety & Risc Management, MSD
Omar Aimer, Pharmacovigilance and drug safety specialist, Rymond Poincaré Hospital - APHP
4) AI in PV- How can AI transform your PV processes
Steven Bailey, Vice President, Worldwide Safety Strategy, Pfizer Pharmaceuticals
5) Patient centric PV- How to deliver a patient centric pharmacovigilance program
Michele Hooper, Senior Director Drug Safety, Kite, A Gilead Company
Jay Duhig, Head, Risk Communication and Behavioral Systems, AbbVie
6) Harmonizing PV- How do you harmonize your PV across a global network and cross functionally effectively?
Rawad Antoun, Manufacturing Site Pharmacovigilance Representative, CSL Behring
Esther Perez, Associate Director, Clinical Project Management, Eli Lilly and Company
9) Updated on ICH- Following up on recent ICH updates across the PV space
Peishan Liu-Snyder, Drug Safety Program Manager, Alkermes Inc
Donna Dougherty, Driector Safety Science, Celgene
Michele Walsh, Manager, Regulatory Affairs, CSL Behring
Eric Hudimac, Associate Director, Intarcia Therapeutics Inc
Shelly Brewster, Pharmacovigilance Operations Manager, Intarcia Therapeutics Inc
Jeremy Jokinen, Senior Director, Safety Decision Analytics, AbbVie
8) Risk Management – How to evaluate risk management requirements?
Mariam Abouhossein, Safety Scientist, Genentech
Sarah Mycroft, Director, Clinical Safety Physician, CSL Behring
Kevin Darryl (KD) White, Senior Director, Regional Head (NA) Global Regulatory Affairs, CSL Behring
7) CAR-T- Understanding the safety requirements and monitoring processes for this new therapy class
Apr 1014:30
Conference pass

Advanced text mining techniques: Tapping into rich unsourced data to gain rapid insights into AEDs

BigData & PV
  • Breaking into untapped patient forums such as Patients Like Me and Yahoo Health 
  • Benefitting from social media covering large and diverse populations to give a real-time deep dive into adverse drug reactions
  • Utilizing unsolicited, uncensored data directly from patients 
Veronica Urdaneta, Senior Principal Scientist/ Physician, Merck
Apr 1014:30
Conference pass

The value story: The business-critical rational to invest in drug safety early in the product lifecycle

NEXT GENERATION TECH IN PV
  • Demonstrating value of treatment to move the discussion past pricing 
  • Preparing for early launch success by answering the questions associated with value earlier in the development stage 
  • How CSL Behring demonstrated the value of high cost rare disease treatment with greater emphasis on patient value 
Debbie Drane, Senior Vice President Global Commercial Development, CSL Behring
Apr 1014:30
Conference pass

WEB-RADR: automated screening of social media & mobile reporting app for Pharmacovigilance

PATIENT CENTRIC PV
  • Web-Recognising Adverse Drug Reactions  
  • Embracing new technologies across Novartis
  • Managing Both public and private partnerships in PV projects effectively
  • Reports via mobile app vs established reporting schemes: Establishing the pros and cons in the systems
  • Algorithms and analytics used by Novartis in social media signal detection
  • Develop a policy framework
  • Reshaping the pharmacovigilance world
Apr 1014:50
Conference pass

Using RWE: Predictive analytics to impact patient safety and shorten phase III trials

BigData & PV
  • How to monitor quality and compliance, in near real-time, to address potential issues as quickly as they are identified? 
  • Bridging data access and analytics between study-based safety and post-marketing
  • Using RWE to shorten phase III and accelerate approval procedures
  • Adapting PV departments into cross-functional teams in order to derive expected benefit and value from controlled studies
Ale (Maria) Vazquez-Gragg, VP, Head Global Patient Safety, Intarcia Therapeutics Inc
Apr 1014:50
Conference pass

The value of machine learning in safety

NEXT GENERATION TECH IN PV
Anaupam Agarwal, Head, Global Drug Safety and Pharmacovigilance, Zogenix
Apr 1014:50
Conference pass

Patient-centric pharmacovigilance: building better outcomes through integrated technology

PATIENT CENTRIC PV
  • Patient-centric pharmacovigilance:  building better outcomes through integrated technology 
  • How to monitor quality and compliance, in near real-time, to address potential issues as quickly as they are identified? 
  • Bridging data access and analytics between study-based safety and post-marketing
Mariette Boerstoel, Senior Vice-President, Head Global Drug Safety, Shire Pharmaceuticals
Apr 1015:10
Conference pass

Title TBC

BigData & PV
Bill Kivett, Director of Product Management for ProQuest Dialog and Pi2, ProQuest
Apr 1015:10
Conference pass

SPONSORSHIP AVAILABLE

NEXT GENERATION TECH IN PV
Do you have a solution you would like to share with our audience?
Contact Michael Shackil now on: michael.shackil@terrapinn.com or call at +1 646.619.1809
 
Apr 1015:10
Conference pass

Delivering better operational services via automation: what’s the Reality today?

PATIENT CENTRIC PV
  • Examples of automation based case processing success stories
  • What can be achieved through case processing automation?
  • Safety Analytics
  • Managing expectations: separating the reality from the fantasy
Fran Bates, Vice President of Technology Services, Sciformix Corp
Apr 1015:30
Conference pass

Understanding the key aspects of Benefit Risk Assessments from a regulatory perspective and how the patient is involved in the discussion

BigData & PV
  • How benefit-risk assessments form the fundamental basis of regulatory decision making?
  • Benefit-Risk Assessment initiatives: How to move away from separate contributions of efficacy evidence and risk data to a consolidated meaningful database
  • The patient voice in Benefit-Risk Assessments: How do you include the patient in the benefit: risk assessment at an early stage in drug development?
 
 
Apr 1015:30
Conference pass

Pharmacovigilance Challenges with Common Technology Platforms - viral vectors to lipid nanoparticles

NEXT GENERATION TECH IN PV
  • A regulatory overview of the legal framework toward granting ATMP marketing authorization
  • Discussing differences in regulatory pathways across Europe and the US to aid in driving your Advance Therapy into the clinic
  • Safety lessons learnt from Moderna’s personalized cancer vaccines
Barbara Morollo, Head, Pharmacovigilance Operations, Moderna Therapeutics
Apr 1015:30
Conference pass

Patient engagement in the precision era- making safety personal through the developing of patient centered frameworks

PATIENT CENTRIC PV
  • Embedding a patient centered culture within a drug safety organization in a new era of personalized medicine
  • Developing a framework to engage with patients in an effective manner using technology such as reporting apps
  • Implementing patient centered drug safety and pharmacovigilance in PV operations
Mike Liu, Senior Medical Director, Clinical Safety/PV, AbbVie
Apr 1015:50
Conference pass

Challenges in PV and building a safety organization for new therapy classes such as RNAi and other nanotechnologies

NEXT GENERATION TECH IN PV
  • Showcasing the first in class RNAi therapy to make it to phase III clinical trials with full primary and secondary endpoints hit 
  • Balancing early market access to new drugs with the need for benefit/risk data 
  • Nanotechnology-based Delivery Strategies for RNAi- reducing risks using new delivery systems
Adrian Dana, Senior Director of Clinical Risk Management and Safety Surveillance, Merck Research Laboratories
Apr 1015:50
Conference pass

The patient's voice in Pharmacovigilance: pragmatic approaches to building a patient- centric drug safety organization

PATIENT CENTRIC PV
  • Actively driving patient centricity into your Pharmacovigilance program through cultural changes to deliver the strongest possible results  
  • Collecting and analyzing patient-generated ADR reports for signal detection and evaluation purposes 
  • Distinguishing factors in patient engagement, risk communication and patient preference assessment in the highly competitive pharmaceutical industry landscape 
Kala Jayaram, Drug Safety Medical Director, BioMarin Pharmaceutical Inc.
Apr 1016:10
Conference pass

PV technology disruption in a pragmatic way

NEXT GENERATION TECH IN PV
  • Innovative PV Solutions (EVDAS Integration, Automated Real time Metrics, All-In-One Solution for Case Intake Automation)
  • Pharmacovigilance in the Technological Age (Big Data, Artificial Intelligence, Machine Learning)
  • Advanced technology stack and its applications - PV efficiency gains and High capability-to-cost ratio
  • Machine Learning and NLP for extraction of relevant information (from unstructured information to cases)
  • Model driven approaches for risk and signal management – detection, evaluation and validation
Apr 1017:00
Conference pass

SPONSORSHIP AVAILABLE

Keynotes
Do you have a solution you would like to share with our audience?
Contact Michael Shackil now on: michael.shackil@terrapinn.com or call at +1 646.619.1809
 
Apr 1017:20
Conference pass

Brexit: Outlining the effects on QPPV and the drug safety community internationally

Keynotes
  • Assessing the likely outcomes on UK pharmacovigilance after departure from EU frameworks and structures around drug safety regulations
  • Discussing potential contingency plans for QPPV leaders and organizations in the UK stakeholder environment
  • What are the international implications of Brexit on the pharmacovigilance field?
Virginia Acha, Executive Director, Association of the British Pharmaceutical Industry-ABPI
Apr 1017:40
Conference pass

Aggregate Safety Assessment Planning in Drug Development can

Keynotes
  • Strengthen cross-disciplinary communication and collaboration
  • Enhance the ongoing understanding and characterization of the product safety profile
  • Inform preparation for the integrated safety-related filing documents
William Wang, Executive Director, Clinical Safety Statistics, MSD
Ann Strauss, Merck

Create your personal agenda –check the favourite icon

Apr 1108:45
Conference pass

Opening Remarks

Keynotes
Susan Welsh, Chief Safety Officer, CSL Behring
Apr 1109:00
Conference pass

Harmonizing international PV: The impact of multinational guidance and genetic diversity

Keynotes
  • Evaluating the challenges of international access to emerging markets  
  • Analyzing requirements for greater harmonization of data acceptance between EMA and FDA  
  • Understanding the impact of trial genetic diversity on acceptance 
Esther De La Cuesta, A Head, Oncology TKI/ADCs, GPV Benefit Risk Management, Bayer Corp
Apr 1109:20
Conference pass

Predictive drug safety: Investing in and developing systems for predicting human drug toxicity safety throughout the drug discovery and development process

Keynotes
  • What is the rationale behind implementing predictive drug safety and is it worth the investment? 
  • How to capitalize on the explosion of data linking drugs, proteins, and pathways with safety events through developing integrative systems approaches to large-scale predictive drug safety 
  • Case studies of predictive drug safety in action – who are the key players that you should be watching?  
Apr 1109:40
Conference pass

Mitigating the effects of dramatic changes to big data and safety technology

Keynotes
  • Strategies for streamlining uptake of new PV technology and ensuring seamless responses to the resulting changes
  • Assessing the impact of new signal detection methodologies implemented by the FDA
  • Collaborating with wide networks of colleagues and vendors to harmonize uptake of new technologies in PV
Moderator: William O'Brien, Chairman of Medical Surveillance Team and Virology, Global Pharmacovigilance and Epidemiology, Bristol Myers Squibb
Jose Vega, Chief Safety Officer, Merck & Co., Inc.
Ale (Maria) Vazquez-Gragg, VP, Head Global Patient Safety, Intarcia Therapeutics Inc
Songlin Xue, Executive Vice President and Global Head of Pharmacovigilance, Astellas
Apr 1110:20
Conference pass

Improving risk:benefit assessment with comprehensive data and a quality, compliant safety system

Keynotes
  • Access a range of information from literature, regulatory filings and post-market reports to evaluate safety signals
  • Leverage relevant scientific data to design more effective trials and make strategic risk assessment decisions
  •  Effectively manage literature screening with a GxP compliant, inspection-ready system
Apr 1111:10
Conference pass

Real World Data for biosimilars

PATIENT CENTRIC PV
  • Comparing the key differences between biosimilar PV strategy and generic PV
  • Evaluate the readiness of current PV systems for the influx of new biosimilars
Niraj Chhaya, Lead Risk Management, Global Pharmacovigilance, Boehringer Ingelheim Pharma GmbH & Co. KG
Apr 1111:10
Conference pass

EudraVigilance: How to empower your organization by leveraging the EMA’s new safety platform

BigData & PV
  • Delivering simplified reporting, better quality data and improved searching, enhanced analysis and tracking functionalities
  • Winning extended access for marketing authorization holders 
  • Streamlining implementation with EMA assistance
Walter Straus, Associate Vice-President and Therapeutic Area Head, Infectious Diseases, Vaccines, Medical Devices & Combination Products, Merck And Company
Apr 1111:10
Conference pass

Using machine learning systems to Identify ICSRs and harness the power of digital media in PV

NEXT GENERATION TECH IN PV
  • Machine Learning systems to Identify Individual case safety signals from Social/Digital Media 
  • Performance of Machine Learning Systems for ICSR causality determination 
  • Regulatory perspectives on the use of AI/Machine Learning to assist with pharmacovigilance activities
Shaun Comfort, Assoc Director of Risk Management, Genentech A Member of the Roche Group Inc
Apr 1111:30
Conference pass

Scaling patient-centric throughout your product lifecycle- utilizing behavioral science and novel analytical techniques to get the best for your organization

PATIENT CENTRIC PV
  • Adopting patient centricity at scale through cultural and technological challenges
  • Implementing new surveillance systems whilst maintaining a central focus on the patient
  • Engaging with patients effectively and consistently throughout the process of pharmacovigilance practice 
Jay Duhig, Head, Risk Communication and Behavioral Systems, AbbVie
Apr 1111:30
Conference pass

SPONSORSHIP AVAILABLE

PATIENT CENTRIC PV
Do you have a solution you would like to share with our audience?
Contact Michael Shackil now on: michael.shackil@terrapinn.com or call at +1 646.619.1809
Apr 1111:30
Conference pass

Navigating the complexities of reference safety information regulation: How to react to the latest guidance’s in GRFG RSI

BigData & PV
  • Review of the November 2017 clinical trial facilitation group reference safety information question and answer document
  • Discussion of reference safety information complexities and navigating the changing environment
  • Perspectives on operationalizing reference safety information in the setting of global clinical trial conduct
Apr 1111:30
Conference pass

Developing the fastest drug development to FDA approval in the US

NEXT GENERATION TECH IN PV
  • Accelerating drug approval through investment in PV departments
  • Applying advances in new data analytics technologies to pharmacovigilance models
  • Delivering control, consistency and cost-savings through seamless adaptation of new machine learning technologies
Ed Tucker, Senior Vice President of Medical Safety, Quality and Compliance, Acerta
Apr 1111:50
Conference pass

SPONSORSHIP AVAILABLE

BigData & PV
Do you have a solution you would like to share with our audience?
Contact Michael Shackil now on: michael.shackil@terrapinn.com or call at +1 646.619.1809
Apr 1111:50
Conference pass

SPONSORSHIP AVAILABLE

NEXT GENERATION TECH IN PV
Do you have a solution you would like to share with our audience?
Contact Michael Shackil now on: michael.shackil@terrapinn.com or call at +1 646.619.1809
Apr 1112:10
Conference pass

ROUND TABLES

Keynotes
1) Brexit and QPPV- what are the effects?
Patrick Puplampu, QP&S Manager, Janssen
Virginia Acha, Executive Director, Association of the British Pharmaceutical Industry-ABPI
2) China and PV- Implementing a Pharmacovigilance Support Model following acquisition of a local Company in China
Rawad Antoun, Manufacturing Site Pharmacovigilance Representative, CSL Behring
3) Pharmacovigilance for ATMPs – Developing an understanding of advanced therapy PV methodologies and requirements
Rawad Antoun, Manufacturing Site Pharmacovigilance Representative, CSL Behring
Barbara Morollo, Head, Pharmacovigilance Operations, Moderna Therapeutics
4) Automation of PV- Success sorties and current impacts
5) Defining Value- What is the value of PV in a pharmaceutical company and the importance of investing?
Michael Lusiola, Director, Patient Safety, AstraZeneca
6) Electronic Trial Data Capture- tricks learnt whilst implementing
Mary Furnari, Clinical Trial Manager, Celgene
Shelly Brewster, Pharmacovigilance Operations Manager, Intarcia Therapeutics Inc
Elizabeth Squiers, SVP PV and Clinical Development, Deputy CMO, Quark Pharmaceuticals
7) EudraVigilance - Pharmacovigilance in EEA Data Security- How do you secure your PV data
Suzanne Skarzynski, Global Safety Clinical Risk Management Team Leader, Merck And Company
Tricia Frantz, Clinical Risk Management Associate Principal Scientist, Drug Safety, Merck
8) Drug Safety Pharmacology- New approaches to drug safety
9) Social Media Signal Detection- How has it worked?
Bernard Fermini, Chief Scientific Officer, Pfizer
10) Social Media Signal Detection- How has it worked?
Lilyan Wright, Senior Scientist of Drug Safety Risk Management, Genentech
Christine Durkan, Sr. Scientist - CSRM, Merck
Apr 1114:20
Conference pass

Cooperative approaches to developing pharmacovigilance strategies in emerging markets

PATIENT CENTRIC PV
  • The importance of post-market safety surveillance in global health programs- where have we been missing the mark?
  • Cooperative Approaches to developing PV systems in LMIC’s – working with local health systems to reduce ADEs  
  • Thinking outside the box- challenges and solutions to developing reporting systems across pharmaceutical companies in different LMIC’s- lessons learnt
Apr 1114:20
Conference pass

Aligning Pragmatic Multicriteria Decision Analysis (MCDA) and advanced pharmacoepidemiology in benefit-risk assessments to real-life regulatory constraints

BigData & PV
  • Developing features of pragmatic MCDA EVIDEM [Evidence and Value: Impact on DEcisionMaking] 
  • Addressing real-life regulatory decision-making needs with adaptable decision analysis models
  • Successfully testing the efficacy of benefit risk frameworks through the incorporation of advanced pharmacoepidemiology
Xiaofeng Zhou, Senior Director, Epidemiology | Worldwide Safety and Regulatory, Pfizer
Apr 1114:20
Conference pass

PHARMACOVIGILANCE IN CHINA SHOWCASE Navigating PV in new lands- studies and discussions on the implementation of PV in China

NEXT GENERATION TECH IN PV
  • Implementing a Pharmacovigilance Support Model following acquisition of a local Company in China
  • The evolution of PV regulations and processes under pharmaceutical industry reform in China
  • Approaches to Pharmacovigilance Support Models based on business- Local market vs Global market in China 
Apr 1115:00
Conference pass

Simplifying adverse event reporting and product quality data capture

PATIENT CENTRIC PV
Apr 1115:00
Conference pass

Pharmacovigilance in the future: artificial intelligence driving innovation in adverse event monitoring

NEXT GENERATION TECH IN PV
  • Identify the impact of rapidly advancing technology on adverse event monitoring
  • Challenges and opportunities that AI can bring 
  • Where are current efforts focusing on?
Wenda Brennan, Head of PV, PharmaLex GmbH
Apr 1115:00
Conference pass

SPONSORSHIP AVAILABLE

BigData & PV
Do you have a solution you would like to share with our audience?
Contact Michael Shackil now on: michael.shackil@terrapinn.com or call at +1 646.619.1809
Apr 1115:20
Conference pass

Leveraging genetic diversity In Vitro: evolution or revolution in cardiac safety assessment?

PATIENT CENTRIC PV
  • Predicting clinical adverse events (AEs) in preclinical studies 
  • Providing proof of concept for preclinical trials by recapitulating AES susceptibility in volunteer populations 
  • Reducing clinical attrition by leveraging genetic diversity in preclinical testing
Bernard Fermini, Chief Scientific Officer, Pfizer
Apr 1115:20
Conference pass

Developing new patient centric safety signal detection systems using devices

NEXT GENERATION TECH IN PV
  • Evaluating the efficacy of new drugs via the use of wearable technologies
  • How wearables with EDC can accelerate clinical trials and drug approvals
  • Disrupting clinical design trial and execution to create value for all stakeholders
Apr 1115:20
Conference pass

Structured benefit-risk assessments – How different pharmaceutical companies are implementing new FDA guidance

BigData & PV
  • Regulatory and industry experiences with approaches to structured benefit-risk assessments 
  • Approaches to incorporating patient perspectives into structured benefit-risk assessment 
  • Exploring available methods to advance structured benefit-risk assessment
Apr 1115:40
Conference pass

Drug safety pharmacology- Understanding importance of early stage ADE prediction

PATIENT CENTRIC PV
  • How to leverage a digital transformation platform in your pharmaceutical division to increase efficiencies in later stage safety signal detection 
  • Gaining maximum profitability in the migration via enhancing low code development and rapid migration 
  • Leveraging existing pharmacology technology whilst enhancing processes for optimized outcomes
Tony Bahinski, Global Head, Safety Pharmacology, GSK
Apr 1115:40
Conference pass

Safety signal management and Pharmacovigilance system compliance – key points to drive success from a European Perspective

NEXT GENERATION TECH IN PV
  • Risk mitigation during Medicines products life cycle-New Era for pharmacovigilance compliance 
  • Stakeholders’ engagement strategy in healthcare industry – decision making hierarchy
  • Medicinal products benefit risk assessment - Health authorities’ cluster activities
Apr 1116:00
Conference pass

Safety Science: an integrative approach to patient safety

PATIENT CENTRIC PV
  • Investing in safety- How failures in safety programs have resulted in in of more than half of all project closures in pharmaceuticals?
  • How to predict clinical reactions to the drugs by integrating pharmacology, subject’s predisposition, and drug structure to mitigate ADE’s
  • How a thorough understanding of target, drug structure, and pharmacology at discovery can help predict up to 75% of the adverse drug reactions in the market
Apr 1116:00
Conference pass

Thought processes of middle east pharmacovigilance regulators

NEXT GENERATION TECH IN PV
  • How to submit ICSF in different regions of the middle east
  • How to submit aggregate reports in different regions of the middle east
  • What are regulators looking for registration and re-registration of products from a pharmacovigilance point of view
Apr 1116:00
Conference pass

Are those side effects due to my drug? - The case for clinical toxicology and drug testing in clinical trials

BigData & PV
  • Pharmacogenomics - considerations towards inclusion in clinical trial lab testing
  • Adverse events - case law and laboratory centric aspects for improvement and safety
  • The impact of the opioid epidemic on drug safety and clinical trials
Martin Bluth, Chief Medical Officer, Consolidated Laboratory Management Systems
last published: 18/Jan/18 22:05 GMT