Pharmacovigilance

Dreuil-lès-Amiens, France

Pharmacovigilance

Dreuil-lès-Amiens, France
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DUBLIN, Apr. 20, 2017 /PRNewswire/ -- Research and Markets has announced the addition of the "Pharmacovigilance" conference to their offering. This course aims to provide basic training for those concerned with pharmacovigilance. New entrants as well as experienced operators in...


DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "Introduction to Veterinary Pharmacovigilance" conference to their offering. This course has been designed to provide basis training and a good introduction to those concerned with Veterinary Pharmacovigilance. New entrants, support staff we well as experienced personnel who require a better understanding of veterinary drug safety will benefit from the practical guidance provided. Key terminology will be explained and roles and responsibilities will be clarified. There will be plenty of time for interaction, questions and answers to enable participants to get a good understanding of this complex subject. This course will be beneficial for those new to veterinary pharmacovigilance, support staff and experienced personnel who require a better understanding of drug safety in their current role. Adverse event monitoring and drug safety officers together with regulatory affairs and personnel from registration departments will find this seminar useful. The Current Regulatory Framework and its Global Impact - Overview of European regulatory framework, including Volume IXb and implications of the proposed EU pharmacovigilance legislation - The principles of causality assessment with practical examples Minimising the Impact of Data with Errors - Format and content of the PSUR Discussion will take place throughout the two days For more information about this conference visit http://www.researchandmarkets.com/research/p3crqc/introduction_to


This course aims to provide basic training for those concerned with pharmacovigilance. New entrants as well as experienced operators in drug safety monitoring will benefit from the mixture of scientific knowledge and practical guidance. In addition, detailed information will be provided on regulatory developments in pharmacovigilance in Europe, the USA, and Japan. This three-day introductory course is aimed at personnel in research and development departments, adverse reaction monitoring units, regulatory affairs and registration departments; pharmaceutical physicians and drug safety officers. It will also be of direct benefit to all those who are involved and interested in the daily practice of pharmacovigilance. Key Topics to Be Addressed at the Pharmacovigilance Conference: - Principles of Pharmacovigilance and Data Resources - Risk Management and Risk Minimisation - Causality Assessment: Clinical Diagnosis of Adverse Events - PASS and PAES Studies - Regulatory Framework - European Post-Marketing Pharmacovigilance Regulations - Pharmacoepidemiological Studies - Evolution of PSURs, PBRERs and DSURs - Pro-active Pharmacovigilance Pre- and Post Marketing - Clinical Trial ADR reporting requirements - Risk/Benefit Assessment - Drug Surveillance in countries outside Europe - Examples of pharmacoepidemiological studies used in risk management - Introduction to Signal detection - Introduction to Risk Management plans - Practical Pharmacovigilance Workshop Agenda: Day 1 Schedule 09.00 Registration and coffee 09.30 Principles of Pharmacovigilance and Data Resources - Basic principles of monitoring drug safety - An overview of methodology - Data resources available for monitoring and evaluating drug safety - Responding to drug safety signals Risk Management and Risk Minimisation: Basic Principles - Basic principles - Proactive strategies - Principles of risk minimisation - PASS and PAES studies Causality Assessment: Clinical Diagnosis of Adverse Events - The principles of causality assessment with practical examples - Medical evaluation of individual reports of adverse events - Strategies for follow up The Current Regulatory Framework and its Global Impact - Overview of European regulatory framework, including new EU pharmacovigilance legislation - Implications for global environment - the links to ICH and CIOMs recommendations - Inspections and penalties for non-compliance - Practical applications of definitions European Post-Marketing Pharmacovigilance Regulations Overview of requirements which will include: - The role of Pharmacovigilance Risk Assessment Committee and SCOPE initiative - Quality Management Systems and the - Pharmacovigilance System Master File (PSMF) - QPPV - Expedited Reporting solicited vs spontaneous - Periodic reports and Signal Management - Risk Management Plans and Risk Minimisation - Post Authorisation Safety and Efficacy studies (PASS/PAES) - Additional Monitoring - Pharmacovigilance Inspections/audit - Public Hearings - Stakeholder involvement initiatives such as PROTECT, WEB-RADR 17.15 End of Day One and Drinks Reception Day 2 Schedule 09.30 Pro-Active Pharmacovigilance Pre-and Post Marketing - Anticipating drug safety issues in development of small molecules and biologics - What specific and non-specific safety monitoring should be done? - Handling safety signals in development - Differences between pre-marketing studies and post-marketing experience Risk/Benefit Assessment - General principles - Quantifying risk - Taking action to optimise benefit/risk - Monitoring the effectiveness of risk management measures Clinical: Trial ADR Reporting Requirements - IH E2A and general requirements - Expedited reports - EU Clinical Trials Directive and detailed guidance - US IND requirements - Development Safety Update Reports (DSURs) Pharmacoepidemiology Studies - Basic Designs, Strenghts, Weaknesses and Examples - Real world data is the King - Randomisation in the real world - Drugs and devices - its all exposure - Tracking all patients? Where are We Now with PSURs (or PBRERs) - Evolution of the PSUR, PBRER and DSUR - ICH E2C, Volume 9A, GVP Module VII and ICH E2C (R2) What do we submit now and when is it required? - Practical aspects of compiling PSURs - The link between DSURs, RMPs, PSURs, and Core Safety Information 17.00 Close of day two Day 3 Schedule 09.30 Drug Surveillance in Countries Outside Europe - US culture - NDA and IND safety reporting - Inspections - Japan culture - Post-marketing safety surveillance programmes in Japan - Pharmacovigilance in other countries Practicalities of Signal Detection - Definitions of signals - Regulatory guidances on signal detection by industry and regulators - Resources for signal detection - Quantitative v qualitative signal detection Examples of Pharmacoepidemiological Studies Used in Risk Management - Prescription event monitoring - Prospective observational cohort studies - Case control studies - Drug registries (anti-TNFs) - Pregnancy registries Practicalities of Risk Management A real world example of the development of a successful EU risk management plan - Requirements of risk management plans from an industry point of view - How to write a successful risk management plan - Reporting results of outcomes of activities in the risk management plan - Updating a risk management plan Practical Pharmacovigilance Workshop As requested by previous participants in this course, this session will comprise a practical case study with valuable hands-on experience covering: - Handling an important safety alert from regulators - Assessment of risk - Determining measures to respond to previously unidentified risks - Continuing assessmnet and communication of risk benefit 16.00 Close of day three For more information about this conference visit http://www.researchandmarkets.com/research/2scctz/pharmacovigilance Research and Markets Laura Wood, Senior Manager press@researchandmarkets.com For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/three-day-pharmacovigilance-course-london-united-kingdom---december-4-5-6-2017---research-and-markets-300442736.html


— Orbis Research always aims to bring their clients the best research material and in-depth analysis of the information for any market. This new report Global Pharmacovigilance (PV) software Sales Market for 2017 aims to fulfil the needs of the clients looking for a fresh outlook towards the Global Pharmacovigilance (PV) software Sales Market, or fill in the knowledge gaps with the data available in the report. The well-presented and curated report is compiled by seasoned and professional research experts and subject matter experts in the field. The clients will find the report complete in all aspects as it covers all key components with valuable statistics and expert opinions in all regards. This report studies sales (consumption) of Pharmacovigilance Software in Global market, especially in United States, China, Europe and Japan, focuses on top players in these regions/countries, with sales, price, revenue and market share for each player in these regions, covering Get a PDF Sample of Market Report at: http://www.orbisresearch.com/contacts/request-sample/281514 Market Segment by Regions, this report splits Global into several key Regions, with sales (consumption), revenue, market share and growth rate of Pharmacovigilance Software in these regions, from 2011 to 2021 (forecast), like Split by product Types, with sales, revenue, price and gross margin, market share and growth rate of each type, can be divided into Split by applications, this report focuses on sales, market share and growth rate of Pharmacovigilance Software in each application, can be divided into Also, some key information such as the cost analysis, industrial chain, sourcing strategy, distributors, marketing strategy, and factor analysis of the Global Pharmacovigilance (PV) software Sales Market are all a part of the report. The report concludes with the customary SWOT analysis and the analysis on investment feasibility and returns. As always has been the aim at Orbis Research with every report put up, the information on offer is complete and true knowledge seekers will benefit from it. Irrespective of the interest, academic or commercial, the Global Pharmacovigilance (PV) software Sales Industry report curated and compiled by domain experts will definitely shed light on key information which the clients require. Chapter One: Pharmacovigilance (PV) software Overview 1.1 Product Overview and Scope of Pharmacovigilance (PV) software 1.2 Classification of Pharmacovigilance (PV) software 1.2.1 Adverse Event Reporting Software 1.2.2 Drug Safety Audits Software 1.2.3 Issue Tracking Software 1.2.4 Fully Integrated Software 1.3 Applications of Pharmacovigilance (PV) software 1.3.1 Pharma and Biotech Companies 1.3.2 Contract Research Organizations (CROs) 1.3.3 Business Process Outsourcing (BPO) Firms 1.3.4 Other Pharmacovigilance Service Providers 1.4 Pharmacovigilance (PV) software Market by Regions 1.4.1 USA Status and Prospect (2011-2021) 1.4.2 China Status and Prospect (2011-2021) 1.4.3 Europe Status and Prospect (2011-2021) 1.4.4 Japan Status and Prospect (2011-2021) 1.4.5 India Status and Prospect (2011-2021) 1.4.6 Southeast Asia Status and Prospect (2011-2021) 1.5 Global Market Size (Value and Volume) of Pharmacovigilance (PV) software (2011-2021) 1.5.1 Global Pharmacovigilance (PV) software Sales and Growth Rate (2011-2021) 1.5.2 Global Pharmacovigilance (PV) software Revenue and Growth Rate (2011-2021) Chapter Two: Global Pharmacovigilance (PV) software Competition by Manufacturers, Type and Application 2.1 Global Pharmacovigilance (PV) software Market Competition by Manufacturers 2.1.1 Global Pharmacovigilance (PV) software Sales and Market Share of Key Manufacturers (2011-2016) 2.1.2 Global Pharmacovigilance (PV) software Revenue and Share by Manufacturers (2011-2016) 2.2 Global Pharmacovigilance (PV) software (Volume and Value) by Type 2.2.1 Global Pharmacovigilance (PV) software Sales and Market Share by Type (2011-2016) 2.2.2 Global Pharmacovigilance (PV) software Revenue and Market Share by Type (2011-2016) 2.3 Global Pharmacovigilance (PV) software (Volume and Value) by Regions 2.3.1 Global Pharmacovigilance (PV) software Sales and Market Share by Regions (2011-2016) 2.3.2 Global Pharmacovigilance (PV) software Revenue and Market Share by Regions (2011-2016) 2.4 Global Pharmacovigilance (PV) software (Volume) by Application Chapter Three: USA Pharmacovigilance (PV) software (Volume, Value and Sales Price) 3.1 USA Pharmacovigilance (PV) software Sales and Value (2011-2016) 3.1.1 USA Pharmacovigilance (PV) software Sales and Growth Rate (2011-2016) 3.1.2 USA Pharmacovigilance (PV) software Revenue and Growth Rate (2011-2016) 3.1.3 USA Pharmacovigilance (PV) software Sales Price Trend (2011-2016) 3.2 USA Pharmacovigilance (PV) software Sales and Market Share by Manufacturers 3.3 USA Pharmacovigilance (PV) software Sales and Market Share by Type 3.4 USA Pharmacovigilance (PV) software Sales and Market Share by Applications About Us: Orbis Research (orbisresearch.com) is a single point aid for all your market research requirements. We have vast database of reports from the leading publishers and authors across the globe. We specialize in delivering customised reports as per the requirements of our clients. We have complete information about our publishers and hence are sure about the accuracy of the industries and verticals of their specialisation. This helps our clients to map their needs and we produce the perfect required market research study for our clients. For more information, please visit http://www.orbisresearch.com/reports/index/global-pharmacovigilance-pv-software-sales-market-2017-industry-trend-and-forecast-2022


TORONTO, ON--(Marketwired - May 12, 2017) - Axiom Real-Time Metrics, the premier provider of eClinical software solutions and services to small to mid-sized life sciences organizations, will be exhibiting at the Advances in Immuno-Oncology Congress taking place in London, UK, on May 15-16, 2017. The Advances in Immuno-Oncology Congress will gather 200 delegates from world renowned academic institutions, hospitals, pharmaceutical organisations, and biotechnology companies. Attendees are invited to join Axiom team members at Booth 9, including Andrew Schachter, CEO and Founder, and Dr. Robert Arbeit, Chief Clinical Scientist, to learn more about Axiom's Fusion eClinical suite and the unified modules Randomization, Inventory Management, and Safety Management. "Our team is excited to meet with attendees and share information about the benefits and value of our award winning unified eClinical suite, Fusion. It delivers a connected hub that enables sponsors to manage every aspect of their study from a single log-on. This includes EDC, DM, IWRS, inventory management, payment tracking and so much more. We are always excited to share and illustrate what the distinction of being 'Truly Unified' really means and what sets us apart," says Andrew Schachter, CEO and Founder. "The Fusion eClinical suite provides uniquely tailored reports to support clinical oncology studies, including tumour response assessment and tracking, patient profiles and biomarker reports. Axiom has delivered solutions for global oncology studies for the treatment of Multiple Myeloma, Breast Cancer and Leukemia, among others," shared Dr. Robert Arbeit, Axiom's Chief Clinical Scientist. Headquartered in Toronto, Canada, Axiom delivers intuitive, powerful and cost-effective eClinical solutions and services focused around your entire study. Services include: DM, Biostatistics and Pharmacovigilance. Axiom's eClinical suite, Fusion, delivers a powerful range of innovative end-user focused, unified functionality and 15 modules. Axiom serves as the Connected Hub for your entire clinical study data and operational needs. Fusion Delivers: EDC, DM, IWRS, CTMS, Inventory Management, IVR, Patient Portal, AE/SAE Tracking, Safety Database, Central Lab, Imaging, eTMF, and 24/7 Project and Clinical Data Reporting. For more information, please visit http://www.axiommetrics.com/.


Third in the series Four Steps to Shorten Your Clinical Trials with Informatics TORONTO, ON--(Marketwired - May 25, 2017) - This webinar taking place on Monday, June 12, 2017 discusses how drug safety teams can use dynamic visual analytics to uncover safety issues earlier while complying with extremely complex and ever-evolving regulatory requirements. The speakers, Masha Hoffey, Director of Clinical Analytics, and James Powers, Director of Real World Evidence and Data Science, both from PerkinElmer's Informatics team will also provide recommendations for advanced analytics on real-world data and active surveillance for a proactive PV platform. This webinar taking place on Monday, June 12, 2017 discusses how drug safety teams can use dynamic visual analytics to uncover safety issues earlier while complying with extremely complex and ever-evolving regulatory requirements. The speakers, Masha Hoffey, Director of Clinical Analytics, and James Powers, Director of Real World Evidence and Data Science, both from PerkinElmer Informatics will also provide recommendations for advanced analytics on real-world data and active surveillance for a proactive PV platform. This is the third in the series Four Steps to Shorten Your Clinical Trials with Informatics. This series explores proven ways to develop go/no-go insights faster so clinical development teams can: For more information about this complimentary webinar, visit: Uncover Pharmacovigilance Insights with Data Discovery and Active Surveillance Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year thousands of industry practitioners (from pharmaceutical & biotech companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers. To learn more about Xtalks visit http://xtalks.com


DUBLIN, May 26, 2017 /PRNewswire/ -- Research and Markets has announced the addition of the "PV (Pharmacovigilance) Audit Strategy Planning - A Practical Approach to Design and Implementation" conference to their offering. The European Medicines Agency's (EMA) Guideline on good...


The European Medicines Agency's (EMA) Guideline on good pharmacovigilance practices (GVP), Module IV requires that risk-based audits of the quality system be performed at regular intervals to assure that it complies with the established quality requirements and to determine its effectiveness. It includes audit of the pharmacovigilance system which is covered by the quality system. The GVP Modules are applicable to EU-based companies and any company marketing medicinal products on a global basis. The legally required risk based audit strategy shall cover all PV processes and tasks undertaken by or delegated to other departments, MAH affiliates, and third parties such as distributors, external service providers, partners (the PV Universe). The PV Audit Strategy Plan is used to prepare the PV audit program, i.e. annual PV Audit Schedule. In this two day workshop conference we will review the EMA and FDA requirements regarding Risk Based Audits of the PV system and Quality System. The course will focus on the design of the PV audit used strategy, identification of the PV processes and entities subject to PV audit (define the PV audit universe), development of risk assessment methodology, development of procedures/tools to monitor PV processes and activities, and implementation of the PV audit strategy plan. Additionally, we will review methods of quality oversight and management of third parties performing PV activities. Understand the FDA and EMEA's requirements for a risk based audit program and current interpretation. Plan, develop and implement the PV Audit Strategy Plan, which includes the following processes: - Develop a high-level PV audit strategy - Identify the PV activities and processes subject to PV audit - Develop risk assessment criteria - Identify the PV audit universe - entities subject to PV audit - Categorize the entities subject to PV audit - Perform risk assessments - Prioritize entities for audit according to relative risk - Prepare a 3-5 year PV audit plan - Identify procedures/tools to monitor PV quality of third parties This course is designed for people with some PV experience and tasked with developing, maintaining, updating and/or reviewing the PV quality system audit strategy plan, risk assessment and/or the annual PV audit schedules. It is also beneficial for staff responsible for the quality oversight of third parties conducting PV activities. The following personnel will benefit from the course: - PV Quality Assurance Staff - PV Compliance professionals - Quality auditors - Pharmacovigilance Auditors - Relevant Pharmacovigilance Staff - PV Service Provider Relationship Managers - MAH Affiliates responsible for Pharmacovigilance There will be a 15 minute morning break, 1 hour lunch break, and 15 minute afternoon break on each training day. Day 01 (8:30 AM - 4:30 PM) 08.30 AM - 09.00 AM: Registration 09.00 AM: Session Start - Review of FDA and EMEA requirements for risk based PV audits - The pharmacovigilance system and the quality system - Strategic level audit planning - Hands on exercise - PV activities and processes subject to PV audit - Risk assessment criteria - The PV audit universe - all entities subject to PV audit - Safety data exchange agreements (SDEAs) and vendor contracts Day 02 (8:30 AM - 4:30 PM) - Stability (shelf-life) studies - Categorization of the entities (PV Audit Universe) - Risk assessments - Prioritization of entities for audit according to relative risk - 3-5 year PV audit plan - Hands on exercise - Procedural documents, e.g. SOPs - Identify procedures/tools to monitor PV quality for oversight of third parties - Q & A For more information about this conference visit http://www.researchandmarkets.com/research/v78btz/pv To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/pv-pharmacovigilance-audit-strategy-planning-workshop-understand-the-requirements-for-a-risk-based-audit-program-and-current-interpretation-san-francisco-ca-united-states---november-9-10-2017---research-and-markets-300464433.html


This two-day comprehensive Course on Latin America Regulatory compliance requirements will cover topics ranging from pre-clinical and clinical requirements through product registration, amendments and renewals across Pharmaceuticals, Biologics, Medical Devices and Combination Products. The Course will address the structure of the regulatory agencies in Latin America and discuss local cultural nuances to help you be successful in working with the regulators. This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Latin America. The primary countries covered will include: Argentina, Brazil and Mexico. Other countries such as Chile, Costa Rica, Dominican Republic, Panama, Peru and Venezuela will be discussed. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Latin America. Content will include descriptions of the methods by which regulators in the corresponding agencies process filings and registrations and what is expected in the authorization and dossier maintenance of the wide array of licensed products. The current regulatory climate in Latin America is discussed in detail and several examples will be provided to illustrate effective compliance procedures and techniques. Common issues that have caused difficulties for Life Sciences firms in the region are outlined. Course content will explain how Latin America interacts with and utilizes ICH standards and how they relate with other National Healthcare Authorities. Additionally, participants will learn how personnel can best address the conflicts, which arise and the best course for resolution. - Regulatory personnel whose responsibilities require knowledge of Latin America's regulatory environment - Administrative staff responsible for ensuring compliance with regulatory filings and overall regulatory compliance requirements will also find this training highly relevant. - QA / QC Personnel - Global Supply Chain personnel - Clinical / Pharma & Device personnel - Manufacturing personnel - Global Business Development personnel - Any sales or general management employee requiring an understanding of how regulations and compliance issues impact the organization Day 01 (8:30 AM - 4:30 PM) 8:30 - 9:00 AM: Registration 9:00 AM: Session Start Time    - LA Overview - LA markets - Harmonization efforts - Understanding the Regulatory Process - Regulatory Overview (gov't offices, organization, contact info) - Brazil - ANVISA - Mexico - COFEPRIS - Argentina - ANMAT - Country Establishment - Clinical Trials - Clinical Trial Start-up - Clinical Trial Application - IND's - Reporting - GCP - Scientific advice - Stability studies - Pharmaceuticals - Marketing Authorizations/Registrations - Registration requirements - Registration documentation/CTD - Summary of Product Characteristics - Package insert - Labeling - Pharmacovigilance/Post-marketing - Amendments/Variations/Changes/Renewals - Fees - Submission Process - Paper filings - Electronic filings Day 02 (8:30 AM - 4:30 PM) - Generics & Bioequivalence - Biologics - Compassionate use - Orphan drugs - Medical Devices - Device Classification - Testing Standards - Registrations - Amendments/Variations/Renewals - Cost build-up model - Fees - Post-marketing - Combination products - Patents/Copyrights/Trademarks - Import/Export procedures - Tax exemptions - Advertising/Promotion - Comparing & Contrasting LA and US - Challenges in Latin America - Influencing the Regulatory Process - Conclusions & summary For more information about this conference visit http://www.researchandmarkets.com/research/5jwj8q/latin_america To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/two-day-seminar-latin-america-regulatory-compliance-requirements-for-life-science-products-with-focus-on-brazil-mexico-argentina-san-diego-ca-united-states---november-9-10-2017---research-and-markets-300464439.html


News Article | May 11, 2017
Site: www.businesswire.com

LONDON & WILMINGTON, N.C.--(BUSINESS WIRE)--Chiltern, a leading global contract research organization, will host a complimentary Xtalks webinar, “Imaging Diagnostics and Theranostics: Meeting Clinical Development Challenges.” The live session will feature thought leaders from Chiltern speaking about the new tools that have evolved in the imaging diagnostic and theranostic space and the opportunities they provide to improve the diagnosis and treatment of cancers and other diseases. “Although challenges remain, this is an exciting time to be in clinical research,” said Sapna Hornyak, MS, MBA, executive vice president, medical device & diagnostics. “This presentation will introduce viewers to the diagnostic and theranostic agents currently under development and discuss the ways they are being implemented and utilized.” Among the key topics to be discussed are innovative tools for diagnostic imaging and treatment of cancers and other diseases, the regulatory expectations for these products, and the clinical development challenges they represent. The webinar will take place May 17 at 10 a.m. (EDT). Register at ChilternWebinar.com. To learn more about this topic or get in touch with Chiltern’s Medical Device & Diagnostics team, visit Chiltern.com or schedule a meeting at the SNMMI 2017 Annual Meeting, June 10–14, in Denver, Colorado. About Chiltern Chiltern, a global contract research organization, is a leading provider of clinical services and solutions in a variety of therapeutic areas with engagement models for biopharmaceutical and medical device industries. Chiltern’s team of more than 4,300, located across 47 countries, provides comprehensive Clinical Development, Medical & Scientific Affairs, Data & Analysis, Pharmacovigilance and Strategic Regulatory services using a collaborative approach for more efficient clinical trials. Visit Chiltern.com to learn more about how Chiltern is Designed Around You®.

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