2019 AGENDA

 

 

Amsterdam, 10 - 11 September 2019

Schedule

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Sep 1008:55
Conference pass

Chair’s opening remarks

Keynotes
Howard Snow, Howard Snow, Head Patient Safety, Sandoz Biopharmaceuticals, Chief Medical Office And Patient Safety, Novartis International AGSwitzerland
Sep 1009:00
Conference pass

Patient-Perspectives in Benefit-Risk Assessments

Keynotes
Songlin Xue, Executive Vice President And Global Head Of Pharmacovigilance, Astellas PharmaUnited States
Sep 1009:20
Conference pass

Re imagining Patient Safety

Keynotes
Innovation is a term that has been thrown around in Pharmacovigilance for years associated with a promise to change the entire PV paradigm, reduce costs, and optimize patient safety outcomes. No longer a distant concept, cognitive automation and a consolidated data repository are now strategic initiatives leveraged by firms globally. These advanced strategies could allow regulators and sponsors to leverage new tools to improve identification of important safety signals and generate more meaningful health care insights. So, what does this actually mean? What are the benefits? What are the risks?And where do we start?Hear from Deloitte as we provide a perspective on how patient safety is being reimagined through the cooperation and lessons learned of industry, regulators, investigators, HCPs, and patients.
Glenn Carroll, Principal, Deloitte Consulting LLPUnited States
Amanda Bowles, Specialist Leader, Deloitte Consulting LLPUnited States
Sep 1010:00
Conference pass

AI and Machine Learning: Using Advanced Technologies to Help Make PV Operations More Efficient

Keynotes
Sep 1013:45
Conference pass

Chair’s remarks

SIGNAL DETECTION & MANAGEMENT
Rudi Scheerlinck, Global Head Pharmacovigilance Risk Management, Nestle Skin HealthSwitzerland
Sep 1013:45
Conference pass

Chair’s remarks

RISK MANAGEMENT
Priya Singhal, Head of Research & Development, Zafgen, Inc.United States
Sep 1013:45
Conference pass

Chair’s remarks

BIG DATA, AUTOMATION & AI IN SAFETY
Arvind Bellur, Senior Director, Head Of Safety Data Management, SanofiUnited States
Sep 1013:45
Conference pass

Chair’s remarks

SAFETY IN THERAPY SPECIFIC AREAS
Dennis Vargo, Vice President, Head of Drug Safety and Pharmacovigilance, Akebia Therapeutics , Inc.United States
Sep 1013:45
Conference pass
Sep 1013:50
Conference pass

Safety Signal detection in rare diseases

SIGNAL DETECTION & MANAGEMENT
Sep 1013:50
Conference pass

The regulatory point of view from PRAC

RISK MANAGEMENT
Liana Gross Martirosyan, Alternate Prac Member, NetherlandsNetherlands
Sep 1013:50
Conference pass

The importance of a safety systems and technology group in a pharmaceutical company

BIG DATA, AUTOMATION & AI IN SAFETY
Arvind Bellur, Senior Director, Head Of Safety Data Management, SanofiUnited States
Sep 1013:50
Conference pass

Pharmacovigilance for Renal Anaemia

SAFETY IN THERAPY SPECIFIC AREAS
Dennis Vargo, Vice President, Head of Drug Safety and Pharmacovigilance, Akebia Therapeutics , Inc.United States
Sep 1013:50
Conference pass

(No) Regulatory Drug Safety in Cell- and Tissue-based Therapies within Point-of-Care Settings

CASE PROCESSING
  • Health economic analyzes and technical analyzes show a growing market for cell-based point-of-care (PoC) therapeutics.
  • Cell therapeutics manufactured and administered at the point-of-care are considered not to be placed on the market in the regulatory sense and therefore do neither need to be tested in clinical trials before they are used therapeutically on a routine base, nor do they need marketing authorization.
  • The German legislator has realized this challenge and intends in the future to subject PoC therapeutics to a stricter form of pharmacovigilance, which must then also be observed by medical practices and clinics.
Sep 1014:10
Conference pass

Pragmatism in Signal Management- Spreadsheets versus Systems

SIGNAL DETECTION & MANAGEMENT
Humaira Qureshi, Chief Executive Officer, Bioclinica Drug Safety Solutions, BioclinicaUnited Kingdom
Sep 1014:10
Conference pass

Transforming product risk management globally by digitising the capture and processing of adverse events

RISK MANAGEMENT
Sep 1014:10
Conference pass

How to fully leverage Automation in PV - Real Case Study’

BIG DATA, AUTOMATION & AI IN SAFETY
Sep 1014:10
Conference pass

What next for Case Processing?- Impact on Compliance

CASE PROCESSING
Sep 1014:20
Conference pass

PASS Studies and Cancer Drugs: Including update of data presented at EMA

SAFETY IN THERAPY SPECIFIC AREAS
Nawab Qizilbash, Senior Clinical Epidemiologist (Honorary Associate Professor, London School of Hygiene and Tropical Medicine), Oxon EpidemiologyUnited Kingdom
Sep 1014:30
Conference pass

How to perform safety surveillance in one compound with multiple indications, different patient populations.

SIGNAL DETECTION & MANAGEMENT
Marqus Hamwright, Senior Director, ArgenxBelgium
Sep 1014:30
Conference pass

Patient centricity in PRAC

RISK MANAGEMENT
Doris Stenver, Former Chief Medical Officer, Member Of Prac At Ema, Danish Medicines AgencyDenmark
Sep 1014:30
Conference pass

Using Artificial Intelligence to optimize PV workload

BIG DATA, AUTOMATION & AI IN SAFETY
  • AI to improve speed and security of adverse event case processing
  • How AI will allow early detection of potential drug-related side effects
  • How can we guarantee regulatory compliance using these tools?
  • Using AI to facilitate organizational design and standardize data
Omar Aimer, Pharmacovigilance specialist, Brunel-SanofiUnited States
Sep 1014:30
Conference pass

PSMF, license partner audit – requirement & burden

CASE PROCESSING
Sep 1014:50
Conference pass

Chair’s remarks

SIGNAL DETECTION & MANAGEMENT
Maria Tello, Head Of Safety, Rakuten MedicalUnited States
Sep 1014:50
Conference pass

Chair’s remarks

RISK MANAGEMENT
Jaylaxmi Nalawade, Associate Director, Lupin LtdUnited States
Sep 1014:50
Conference pass

Chair’s remarks

PV OUTSOURCING
Katrien Soleme, Head Of Global Quality Regulatory Compliance And Clinical Trials And Safety, Bristol Myers SquibbBelgium
Sep 1014:50
Conference pass

Chair’s remarks

CASE PROCESSING
Howard Snow, Howard Snow, Head Patient Safety, Sandoz Biopharmaceuticals, Chief Medical Office And Patient Safety, Novartis International AGSwitzerland
Sep 1014:55
Conference pass

A second use of Eudravigilance data

SIGNAL DETECTION & MANAGEMENT
Bert Van Leeuwen, Deputy Qppv, Astellas Pharma Europe BVNetherlands
Sep 1014:55
Conference pass

Patient centric risk minimization

RISK MANAGEMENT
John Solomon, Head Of Pharmacovigilance, SanofiUnited Kingdom
Sep 1014:55
Conference pass

Case Processing Enabled with Artificial Intelligence – A Journey

BIG DATA, AUTOMATION & AI IN SAFETY
Adrian Maynier, Project Lead, UCBUnited Kingdom
April Davis, Global Pharmacovigilance Industry Director, AccentureUnited States
Sep 1014:55
Conference pass

Service Provider Management

PV OUTSOURCING
Sep 1014:55
Conference pass

Patient centric case processing

CASE PROCESSING
Mate Balazs, Country Head – Patient Safety – Hungary National QPPV – Hungary, Novartis Pharma AGHungary
Sep 1015:15
Conference pass

Practical application of PV download in mid-sized companies with Eudravigilance

SIGNAL DETECTION & MANAGEMENT
Albert Befki, Head of Global PV Operations, Gedeon Richter PlcUnited Kingdom
Sep 1015:15
Conference pass

Risk management in a Generics Company

RISK MANAGEMENT
Jorgen Matz, Head Of Global Pharmacovigilance And Drug Safety, Insud PharmaSpain
Sep 1015:15
Conference pass

Pharmacovigilance monitoring and automation in social media

BIG DATA, AUTOMATION & AI IN SAFETY
  • How it has or has not worked and potential ways to implement it in your company prescriptions and instructions can decrease errors and adverse events
Tarik Messaoud, Drug Safety Specialist Pharmacovigilance Specialist, MerckUnited States
Sep 1015:15
Conference pass

PANEL: Harmonization across the safety ecosystem – Do we have the right priorities

CASE PROCESSING
  • Developing harmonisation as a multinational company
  • Challenges being faced by industry as a whole with a disparate pharmacovigilance regulatory ecosystem.
  • Challenges and solutions being used to overcome global monitoring.
  • Projects in motion to curate a more harmonised pharmacovigilance ecosystem.
Vipin Sethi, Head – Global Pharmacovigilance and Medical Affairs, Cadila PharmaceuticalsIndia
Sep 1015:25
Conference pass

Outsourcing PV audits

PV OUTSOURCING
Carola Gómez De La Bárcena, QPPV, Laboratorios Farmaceuticos RoviSpain
Sep 1015:35
Conference pass

Signal management – implementing the postmarketing process into clinical trials arena

SIGNAL DETECTION & MANAGEMENT
  • robust, structured signal detection using clinical data.
  • well documented decision on ADRs (and their characteristics).
  • Facilitating creation/maintenance of RSI to accommodate CTFG requirements.
Mircea Ciuca, Global Therapeutic Area Head Of Global Clinical Safety And Pharmacovigilance, CSL BehringSwitzerland
Sep 1015:35
Conference pass

Expectations, Promises and Reality: AI adoption in PV

RISK MANAGEMENT
Saeed Amin, Managing Director, NHTUnited States
Sep 1015:35
Conference pass

The Future of Drug Safety: Predictions for 2025

BIG DATA, AUTOMATION & AI IN SAFETY
Sep 1016:25
Conference pass

Chair’s remarks

SIGNAL DETECTION & MANAGEMENT
Lionel Van Holle, Safety Surveillance Lead, UCBUnited Kingdom
Sep 1016:25
Conference pass

Chair’s remarks

RISK MANAGEMENT
Jaylaxmi Nalawade, Associate Director, Lupin LtdUnited States
Sep 1016:25
Conference pass

Chair’s remarks

BIG DATA, AUTOMATION & AI IN SAFETY
Nawab Qizilbash, Senior Clinical Epidemiologist (Honorary Associate Professor, London School of Hygiene and Tropical Medicine), Oxon EpidemiologyUnited Kingdom
Sep 1016:25
Conference pass

Chair’s remarks

PV OUTSOURCING
Wivina De Waele, Regional Drug Safety Office, Alexion PharmaceuticalsSwitzerland
Sep 1016:25
Conference pass

Chair’s remarks

CASE PROCESSING
Andrea Maulwurf, Head Of Pharmacovigilance, Eu-Qppv, Allergy TherapeuticsGermany
Sep 1016:30
Conference pass

Optimizing quantitative signal detection in a multi-database & multi-criteria environment

SIGNAL DETECTION & MANAGEMENT
  • Robust, structured signal detection using clinical data.
  • Well documented decision on ADRs (and their characteristics).
  • Facilitating creation/maintenance of RSI to accommodate CTFG requirements.
Lionel Van Holle, Safety Surveillance Lead, UCBUnited Kingdom
Sep 1016:30
Conference pass

Using Inspection Metrics for Analytical Insight in to Deficiencies in PV System

RISK MANAGEMENT
  • Current Metrics published by Health Authorities
  • Analysis of the metrics to understand the general deficiency trends
  • Lessons learnt to prevent such deficiencies & be in ‘Inspection Ready’ mode
Moin Don, Chief Executive Officer And Founder, P.V.C.O.N. Pharmacovigilance Auditing and Consulting ServicesIndia
Sep 1016:30
Conference pass

Predicting patient safety by analysing clinical trial data or real-world data using AI methods

BIG DATA, AUTOMATION & AI IN SAFETY
  • AI methods, particularly, deep learning and reinforcement learning, offer us novel approaches to gain medical insights about patient safety.
  • Cutting edge AI methods for patient safety prediction will be reviewed including methods developed by Goolge and several top AI research institutes.
  • Application of AI methods in Sanofi will be showcased.
Qi Tang, Associate Director Of Digital and Data Sciences, SanofiUnited States
Sep 1016:30
Conference pass

Ensuring Effective Sponsor-Vendor Relationships

PV OUTSOURCING
  • How to Identify the appropriate work for contracting
  • Ensure rigorous oversight of the project (contracts, metrics)
  • The importance of good communication between sponsor and vendor
Sep 1016:30
Conference pass

How to expand a safety department from National to Global

CASE PROCESSING
  • Safety department involvement in pre-launch activities
  • Signing a PVA and establishment of a local safety system
  • Surveillance of the local PV system
Andrea Maulwurf, Head Of Pharmacovigilance, Eu-Qppv, Allergy TherapeuticsGermany
Sep 1016:50
Conference pass

Signal detection and management in a small clinical development organization?

SIGNAL DETECTION & MANAGEMENT
Ashish Jain, Associate Director, Syros PharmaceuticalsUnited Kingdom
Sep 1016:50
Conference pass

Drug Safety-related Labeling Information and Market Access Implications

RISK MANAGEMENT
Nneka Onwudiwe, Founder And Chief Executive Officer, Pharmaceutical Economics Consultants of America (PECA) LLCUnited States
Sep 1016:50
Conference pass

Safety Reporting Reference Model: Optimizing Global Safety Reporting in Clinical Trials using Local Laws

BIG DATA, AUTOMATION & AI IN SAFETY
Steven Beales, SVP, Scientific and Regulatory, WCG ClinicalUnited States
Sep 1016:50
Conference pass

Managing a strategic service provider on behalf of local safety affiliates, how the local and global can work together and benefits of a model like this

PV OUTSOURCING
Manni Kuthiala, Pv Affiliate Strategic Alliance Manager, RocheSwitzerland
Sep 1016:50
Conference pass

Using a vendor for end to end case processing

CASE PROCESSING
Jefferson Guillon, Pharmacovigilance Manager And Eea Qppv, SeqirusUnited Kingdom
Sep 1017:10
Conference pass

Chair’s remarks

SIGNAL DETECTION & MANAGEMENT
Scott Chandler, Vice President And Global Head Licensing And Early Development (Lead) Safety, F. Hoffmann - La RocheSwitzerland
Sep 1017:10
Conference pass

Chair’s remarks

RISK MANAGEMENT
Peter De Veene, Qppv, Alexion PharmaceuticalsUnited Kingdom
Sep 1017:10
Conference pass

Chair’s remarks

BIG DATA, AUTOMATION & AI IN SAFETY
Nawab Qizilbash, Senior Clinical Epidemiologist (Honorary Associate Professor, London School of Hygiene and Tropical Medicine), Oxon EpidemiologyUnited Kingdom
Sep 1017:10
Conference pass
Sep 1017:15
Conference pass

Proactive Approach to Patient-Centric Safety

SIGNAL DETECTION & MANAGEMENT
Scott Chandler, Vice President And Global Head Licensing And Early Development (Lead) Safety, F. Hoffmann - La RocheSwitzerland
Sep 1017:15
Conference pass

EU HaRP Project for RMPs

RISK MANAGEMENT
  • The presentation provides an overview of the ongoing project for Harmonization of Risk Management Plans in the European Union.
  • Clean-up of disharmonized List of Safety Concerns for existing RMPs.
  • Prospective development of up-to-date RMPs for INNs for which data exclusivity will expire soon.
Adi Meister, Safety Strategy, Teva PharmaceuticalsGermany
Sep 1017:15
Conference pass

Automation Innovation

BIG DATA, AUTOMATION & AI IN SAFETY
Salvatore Giorgio Cicirello, Senior Director Pharmacovigilance Innovation, Global Drug Safety And Risk Management, CelgeneSwitzerland
Sep 1017:15
Conference pass

Safety in personalized medicine

SAFETY FOR ADVANCED THERAPIES
Steinar Madsen, Medical Director, Norwegian Medicines Agency, NorwayNorway
Sep 1017:15
Conference pass

A right size PV system – How harmonized or disharmonized are we

CASE PROCESSING
  • The presentation provides an overview of recent regulatory developments highlighting emerging divergence from EU-GVP
  • Divergent regional requirements for key PV requirements such PSURs, RMPs, PSMF and LQPs are visualised as world maps
  • Key recommendations to drive for more convergence are made
Sep 1017:35
Conference pass

Oversight and tracking of risk minimisation activities (from planning to execution)

RISK MANAGEMENT
Peter De Veene, Qppv, Alexion PharmaceuticalsUnited Kingdom
Sep 1017:35
Conference pass

Understanding and optimising your PV operations: a practical approach to unit based costing

BIG DATA, AUTOMATION & AI IN SAFETY
Shani Thilak, Senior Manager - Advisory, Kinapse LtdUnited Kingdom
Sep 1017:35
Conference pass

Evaluation of quantitative signal detection for Orphan Drugs in big databases (e.g Eudravigilance). Possible risks of false negatives.

SAFETY FOR ADVANCED THERAPIES
Sep 1017:45
Conference pass

The Nonclinical Innovation and Patient Safety Initiative (NIPSI): Supporting Human-Based Nonclinical Approaches Through Global Advances in Regulation, Policy, Science, Education and Training

SIGNAL DETECTION & MANAGEMENT
  • Recent initiatives, such as the United States Food and Drug Administration’s (FDA) Predictive Toxicology Roadmap and the Interagency Coordinating Committee on the Validation of Alternative Methods’ (ICCVAM) Strategic Roadmap for Establishing New Approaches to Evaluate the Safety of Chemicals and Medical Products in the United States, represent a fundamental shift in how drugs will be developed and regulated.
  • The Nonclinical Innovation and Patient Safety Initiative (NIPSI) formed to foster stakeholder collaboration – among federal agencies, the private sector, and patient, health and research organizations - that supports innovative human-based science and addresses the factors that impede the uptake of modern, predictive approaches.
  • This presentation describes recommendations for advancing the uptake of human-relevant nonclinical approaches published by NIPSI along with project updates. One project aims to change U.S. Food and Drug Administration (FDA) and International Council on the Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) regulations from requiring “animal” data to “nonclinical,” which encompasses animal in vivo and human and animal-based in vitro and in silico approaches.
Sep 1017:45
Conference pass

Monitoring and engaging with vendors to ensure safety monitoring is followed

CASE PROCESSING
Sep 1017:55
Conference pass

Risks in RMPs and PBRERs, why we do not aim to align

RISK MANAGEMENT
Marcus Schartau, Safety Surveillance Risk Management Specialist, Safety Surveillance, Novo Nordisk A/SDenmark
Sep 1017:55
Conference pass

Rapid ID of safety signals with the help of AI

BIG DATA, AUTOMATION & AI IN SAFETY
Anupam Agarwal, Vice President Global Head Of Drug Safety And Pv, ZogenixUnited States
Sep 1017:55
Conference pass

Showcase Session: Tips on writing fully integrated Clinical Evaluation Reports with risk management, PMS and vigilance

SAFETY FOR ADVANCED THERAPIES
  • Listing residual risks, uncertainties and unanswered question
  • Planning for PMCF studies- Collecting the right data
  • Fully integrate CER with risk minimization
  • Evaluation of the acceptability of benefit risk profile

Create your personal agenda –check the favourite icon

Sep 1109:05
Conference pass
Sep 1109:10
Conference pass

Evolving safety as a value provider rather than a pure necessity

Keynotes
Sep 1109:30
Conference pass

Perspective for utilising artificial intelligence in Pharmacovigilance

Keynotes
Patrick Caubel, Senior Vice President, Pharmacovigilance, PfizerFrance
Sep 1110:00
Conference pass

Keynote Panel: Importance of proactively addressing safety early in development

Keynotes
- Using safety as a differentiator for development decisions- Developing new predictive tools to make assessing safety more strategic- How do you address safety proactively at your company?
Ale Maria Vazquez-Gragg, Vice President Of Global Patient Safety, ArgenxUnited States
Scott Chandler, Vice President And Global Head Licensing And Early Development (Lead) Safety, F. Hoffmann - La RocheSwitzerland
Mariette Boerstoel-Streefland, Senior Vice President Of Pharmacovigilance And Drug Safety, Alexion PharmaceuticalsUnited States
Sep 1113:20
Conference pass

Chair’s remarks

VACCINE SAFETY
Andrew Olaharski, Senior Director And Head Of Toxicology, K.S.Q. TherapeuticsUnited States
Sep 1113:20
Conference pass

Chair’s remarks

REAL WORLD EVIDENCE
Jorgen Matz, Head Of Global Pharmacovigilance And Drug Safety, Insud PharmaSpain
Sep 1113:20
Conference pass
Sep 1113:25
Conference pass

Making safer medicines: Improving labelling and packaging to prevent medication errors

SAFETY & LABELING
  • Labelling and packaging problems are the cause of 33% of medication errors.
  • Main reasons of this problems are look-alike names, low readability and low visibility.
  • It is possible to improve labelling and packaging to mitigate this risk
Sep 1113:25
Conference pass

Benefit-risk assessment of vaccines

VACCINE SAFETY
Nicolas Praet, Senior Epidemiologist Director, GlaxoSmithKlineBelgium
Sep 1113:25
Conference pass

Pharmacovigilance in the middle east

REGULATION
Syed Zaferuddin, Deputy Qppv+ Pharmacovigilance And Clinical Trial Manager, JulpharSaudi Arabia
Sep 1113:25
Conference pass

Real World Evidence in Drug Safety

REAL WORLD EVIDENCE
Mariette Boerstoel-Streefland, Senior Vice President Of Pharmacovigilance And Drug Safety, Alexion PharmaceuticalsUnited States
Sep 1113:25
Conference pass

AI and PV workshop

BIG DATA, AI AND AUTOMATION IN DRUG SAFETY
  • Prioritization
  • Building expertise
  • Validation and Implementation
Sep 1113:45
Conference pass

Update of PV planning and labelling in Japan

SAFETY & LABELING
Shinobu Uzu, Associate Executive Director, Pharmaceuticals and Medical Devices AgencyJapan
Sep 1113:45
Conference pass

Exploring patient support and marketing research programs from a safety perspective

REGULATION
Archi Wani, Principal Map Vendor Compliance Lead Us Drug Safety, Market Research And Patient Support Programs, GenentechUnited States
Sep 1113:45
Conference pass

Challenges, gains and limitations in performing pharmacoepidemiology studies

REAL WORLD EVIDENCE
Jorgen Matz, Head Of Global Pharmacovigilance And Drug Safety, Insud PharmaSpain
Sep 1113:55
Conference pass

Leveraging pharmacology to better predict toxicity

VACCINE SAFETY
  • How do we differentiate amongst exaggerated pharmacology (on-target), pharmacology that manifests in an off-target tissue and off-target pharmacology (secondary pharmacology)?
  • Case study of PLK1 and PLK2 inhibitors
  • How to approach adoptive cell therapy
Andrew Olaharski, Senior Director And Head Of Toxicology, K.S.Q. TherapeuticsUnited States
Sep 1114:05
Conference pass
Sep 1114:05
Conference pass

Hot topics in Asia for Pharmacovigilance

REGULATION
  • Reporting format in China
  • Asian project on PV
  • Standardization
Sep 1114:05
Conference pass

An Open Source Approach for Pharma R&D- Developing Open Knowledge Platforms for Tuberculosis

REAL WORLD EVIDENCE
Nibedita Rath, Scientific Director, Open Source Pharma FoundationUnited Kingdom
Sep 1114:25
Conference pass

Safety & Labeling in non-EU Countries

SAFETY & LABELING
  • Participants will learn about regulatory requirements in the region: Macedonia, Serbia, Montenegro, Bosnia & Herzegovina, Albania and Kosovo
  • Participants will get indepth look at pharmacovigilance compliance concerning safety & labelling and will be updated with the country specific environments
Sep 1114:25
Conference pass

Non-European (Commonwealth of Independent States, CIS) PhV legislation development and implementation into Global requirements

REGULATION
  • PhV legislation development on Post-Soviet area
  • Global challenges and local PhV systems in CIS countries
  • How to implement global requirements into CIS countries
Sep 1114:25
Conference pass

Increasing the accuracy and efficiency of literature surveillance using a hybrid machine learning approach

BIG DATA, AI AND AUTOMATION IN DRUG SAFETY
  • Learn how your organization may be missing reportable literature citations with your current surveillance strategy
  • See the data behind a hybrid machine learning approach and how it can help recapture some of those missed results
Scott Beebe, Director of Product Strategy, Wolters KluwerUnited States
Sep 1115:15
Conference pass
Sep 1115:15
Conference pass

Chair’s remarks

REGULATION
Elena Prokofyeva, Head Of Drug Safety Unit, Department Of R&D, A.F.M.P.SBelgium
Sep 1115:15
Conference pass

Chair’s remarks

REAL WORLD EVIDENCE
Angela Caro Rojas, President, Colombian Pharmacovigilance AssociationColombia
Muhammad Ashar Naeem, Global Director Pharmacovigilance And Medical Affair, Jamjoom PharmaSaudi Arabia
Sep 1115:15
Conference pass

Chair’s remarks

PV IN EMERGING MARKETS
Sep 1115:15
Conference pass

Chair’s remarks

BIG DATA, AI AND AUTOMATION IN DRUG SAFETY
Israel Gutierrez, Vice President Pharmacovigilance And Drug Safety, Geron CorporationUnited States
Sep 1115:20
Conference pass

Safety challenges with allogeneic CAR T therapies

DRUG SAFETY IN BIOSIMILARS & BIOLOGICS
  • Summarizes the differences and similarities between safety issues for autologous CAR-T as compared to allogeneic CAR T
  • Using experience from autologous CAR T, what can we make better
  • Areas in which sponsors can collaborate to avoid the difficulties associated with inconsistent data and analysis methods
Sep 1115:20
Conference pass

Regulatory updates in LatAm and Mexico

REGULATION
Sep 1115:20
Conference pass

Focus Session 1: Patient safety and Pharmacovigilance how we can work together

REAL WORLD EVIDENCE
Angela Caro Rojas, President, Colombian Pharmacovigilance AssociationColombia
Sep 1115:20
Conference pass

Launching products in emerging markets

PV IN EMERGING MARKETS
  • We are experiencing a fast improvement of PV requirement in emerging countries, so that having a qualified distributor is becoming a must.
  • After a brief introduction on the PV general requirement, I will focus on a “Case History”, i.e. how to manage a local distributor which is not qualified (this point is always a challenge with the company Business Dev!!)
  • Emerging difficulties when the local requirement does not match with EU/FDA requirement
  • Future expectation…
Sep 1115:20
Conference pass

Big Data, AI and Automation in Drug Safety

BIG DATA, AI AND AUTOMATION IN DRUG SAFETY
  • Understanding areas and applications for automation
  • Developing AI in drug safety – process and path
  • Effective implementation and impact of ai in drug safety
  • Regulatory acceptance and embracing compliance through automation.
Vivek Poojary, Senior Manager Pharmacovigilance, Alkem Laboratories LimitedIndia
Sep 1115:40
Conference pass

Assessing biosimilar safety: when not exactly the same is no different

DRUG SAFETY IN BIOSIMILARS & BIOLOGICS
Uwe Gudat, Head Of Clinical Safety And Pharmacovigilance Clinical Safety And Pharmacovigilance, Fresenius KabiSwitzerland
Sep 1115:40
Conference pass

CANCELLED/////Focus Session 2: PV outsourcing Merits and demerits

REAL WORLD EVIDENCE
Muhammad Ashar Naeem, Global Director Pharmacovigilance And Medical Affair, Jamjoom PharmaSaudi Arabia
Sep 1115:40
Conference pass

Challenges in entering emerging markets – Perspectives from global PV

PV IN EMERGING MARKETS
Sep 1115:50
Conference pass

Pharmacovigilance quality management system. MAHs’ challenges for compliance

REGULATION
Pharmaceutical industry exerts great effort to monitor the safety profile of their products; ensuring compliance of their pharmacovigilance system via quality standards implementation. The owner of pharmacovigilance qualityj management system (PVQMS) should maintain effective planning and strategy, fulfilling the quality objectives that are not limited to the operational business processes and the involved resources. The Medicines and Healthcare products Regulatory Agency (MHRA) has focused in their pharmacovigilance Inspection Metrics Report (2017/2018) on the increasing complexity of the risky pharmacovigilance systems and the serious breaching of EU legislations. In their report, the PVQMS is contributing to 21 – 25% of the recorded major and critical findings. The health authorities worldwide are stressing on the PVQMS pivotal role in monitoring compliance status of the pharmacovigilance system. This presentation will highlight the key factors for quality management system compliance, expected deliverables and deficiencies` identification, which are essential to strengthen current pharmacovigilance systems.
Sep 1115:50
Conference pass

Business strategy and the implementation of AI

BIG DATA, AI AND AUTOMATION IN DRUG SAFETY
  • Defining an AI strategy that management can support
  • Identifying the best AI solutions to address the organizational need for AI
  • Steps to implementing an AI solution and their impact in the organization
Israel Gutierrez, Vice President Pharmacovigilance And Drug Safety, Geron CorporationUnited States
Sep 1116:00
Conference pass

De-harmonisation: Approaches for handling emerging and diversifying local pharmacovigilance development and periodic reporting requirements

PV IN EMERGING MARKETS
Philippa Evans, Safety Medical Writer, Novo NordiskUnited Kingdom
last published: 11/Sep/19 09:16 GMT

 

 

 

 

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