Become a Sponsor of ISoP 2024

With thanks to the following companies and institutions for their unconditional support of the ISoP 2024 Annual Meeting:

Diamond Sponsors

GalenusRx

The world’s most advanced medication safety organization. GRx flips the reactive model of pharmacovigilance with proactive, predictive, medication safety technology. We streamline the process of forecasting risk of simultaneous multi-drug interactions and adverse drug events using real-world data and predictive analytics identifying safety issues before new drugs enter the market, virtually.

Our APPRAISE ADE Forecasting solution uses quasi-mechanistic, predictive algorithms to derive actionable, context-specific insights to improve drug safety across the entie pre-and post- drug approval lifecycle. These pre-emptive insights are derived from our proprietary assessment of simultaneous multi-drug, drug-gene and drug-disease interactions.

Our APPRAISE Personalized Comprehensive Polypharmacy Engagement solution leverages highly trained and certified Precision Clinical Pharmacists in community settings to support the successful launch and post-launch of new drug entities into the real world. By virtually adding the new drug to individual patients’ medication regimens, considering their existing prescription, OTCs, herbals, recreational drugs, etc., Precision Clinical Pharmacists optimize their medication regimen before starting therapy. Results include the avoidance of preventable adverse drug events, reduced healthcare costs and improved lives.

Learn more! Visit www.galenusrx.com and contact us today:
Orsula V. Knowlton, PharmD, MBA
[email protected]
[email protected]
+1 215-680-8983 | 855-GalenusRx (425-3687)

Gold Sponsors

Fidelity Pharmacovigilance Corp

Also known as Fidelity Health Services

A leading global pharmacovigilance service partner, operates from strategic offices in Toronto (Canada), the USA, the UK and Pune and Ahmedabad (India). Our team of nearly 100 healthcare professionals specializes in providing end-to-end drug safety services. Since 2015, we have been the preferred pharmacovigilance service partner for a top pharmaceutical company, overseeing a diverse product portfolio of over 1,700 products across 30 countries. Fidelity Health Services boasts an impressive regulatory track record, having successfully cleared inspections by major regulatory bodies multiple times. Specifically, we have received clearance from the USFDA on four occasions, Health Canada twice, BfArm Germany twice, and the UK MHRA once.

With over 20 years of experience in the pharmaceutical and clinical research organization industries, the promoters of Fidelity Health Services provide a strong foundation for delivering high-quality and fully compliant pharmacovigilance services. We prioritize understanding our clients’ pharmacovigilance needs and aligning them with relevant regulations, offering resource-optimized and tailor-made services in a budget-friendly manner. Our comprehensive range of services includes end-to-end pharmacovigilance services and customized solutions, such as Medical Information Management, Global and Local Literature Management, ICSR Management, Aggregate Reports, Signal Management, Pharmacovigilance Auditing (3rd party audit), Regulatory Inspection preparedness, and support for ad-hoc pharmacovigilance requirements. Fidelity Health Services is committed to establishing long-term business partnerships with our esteemed clientele across the USA, Canada, the UK, and India. Moreover, we are committed to innovation and are actively developing an AI-enabled tool to enhance drug safety operations, bringing efficiency and accuracy to our services.

AB Cube

Life Sciences Trusted Cloud Software

AB Cube is the developer of the most efficient drug safety database software for life sciences organizations – enabling effortless pharmacovigilance, materiovigilance, cosmetovigilance and nutrivigilance operations in one unified platform. Founded in 2006, Paris-based AB Cube pioneered the industry’s with the first SaaS vigilance application. Now with a presence in 43 countries and serving over 220 international clients, today pharmaceutical laboratories, CROs, pharmaceutical solution organizations and health authorities trust AB Cube’s best-in-class SafetyEasy® Suite to support their global multivigilance needs at every scale.

AB Cube’s intuitive SafetyEasy® Suite delivers a pre-validated, agile and fully compliant solution for global life science companies – integrating intelligent automation to streamline day-to-day activities, reduce manual effort and accelerate reporting processes for safety teams. The AB Cube Galaxy further enhances SafetyEasy® capabilities, offering next-generation vigilance applications to power operations with easy systems integration, cognitive automation for case processing, and 360° vision of data.

Pfizer

Pfizer Canada ULC

is the Canadian operation of Pfizer Inc., one of the world’s leading biopharmaceutical companies. Our diversified health care portfolio includes some of the world’s best known and most prescribed medicines and vaccines. At Pfizer, we apply science and our global resources to bring therapies to people that help extend and improve their lives. We strive to set the standard for quality, safety, and value in the discovery, development, and manufacture of health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments, and cures that challenge the most feared diseases of our time.To learn more about Pfizer Canada, visit pfizer.ca or you can follow us on LinkedIn, Facebook, X, Instagram or YouTube.

UMC Uppsala Monitoring Centre

Our boilerplate

UMC was established in 1978 through an agreement between the World Health Organization (WHO) and the government of Sweden as a WHO Collaborating Centre for International Drug Monitoring. UMC is custodian of the WHO global database of adverse event reports for medicines and vaccines and strengthens global safety surveillance through science and innovation, signal monitoring, development of pharmacovigilance tools, standardisation with the WHODrug dictionary, and education and communication.
www.who-umc.org

Eu2P

Eu2P stands for “European program in Pharmacovigilance and Pharmacoepidemiology“. This consortium, coordinated by the university of Bordeaux, offers an innovative and academic web-based education & training offer in Pharmacovigilance and Pharmacoepidemiology at the worldwide level:

– An accredited Master of Science program : This curriculum includes mandatory and optional course modules, possibly leading to a Master Specialisation Track

– 32 individual accredited Certificates courses : They can be attended on a single basis during the Master curriculum calendar

– 91 individual Short courses : They are bite-sized courses which have been designed out of the Master and Certificate modules’ course material and can be attended at anytime, any-pace.

Eu2P has recently been extended to the Am2P program dedicated to North American stakeholders in collaboration to the NaSOP chapter. Am2P also provides accredited postgraduate certificates and short courses in Pharmacovigilance and Pharmacoepidemiology and can be attended online at anytime, any-pace.

More info at www.eu2p.org and www.am2p-courses.com

Med Communications

MedDRA

Medical Dictionary for Regulatory Activities

In the late 1990s, the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) developed MedDRA, a rich and highly specific standardized medical terminology to facilitate sharing of regulatory information internationally for medical products used by humans. ICH’s powerful tool, MedDRA is available to all for use in the registration, documentation and safety monitoring of medical products both before and after a product has been authorized for sale. Products covered by the scope of MedDRA include pharmaceuticals, biologics, vaccines and drug-device combination products. Today, its growing use worldwide by regulatory authorities, pharmaceutical companies, clinical research organizations and health care professionals allows better global protection of patient health.

The Maintenance and Support Services Organization (MSSO) was established by the (ICH) to manage the Medical Dictionary for Regulatory Activities (MedDRA) terminology. The MSSO serves as the repository, maintainer, and distributor of MedDRA. In this capacity, the MSSO ensures that the integrity of the terminology, as well as its medical correctness, stay intact. The MSSO has maintained the Terminology in a state of control since its receipt of the “Golden Master” version of the terminology and several supporting documents in December 1998. This Quality System Manual (QSM) for the MSSO defines and describes program management responsibilities and MedDRA maintenance and support organization process and product baselines for the MSSO. This QSM provides overarching guidance for the operation and maintenance of the MedDRA Maintenance Quality Management System (QMS).

PharmaSoft

PharmaSoft is recognized as a reputable provider of tailored solutions for the pharmaceutical industry, offering cutting-edge services to empower pharmaceutical companies worldwide. Renowned for its commitment to excellence, PharmaSoft navigates the complex terrain of drug safety, regulatory compliance, and data management with unparalleled expertise and innovation.
Their comprehensive suite of services encompasses end-to-end pharmacovigilance solutions, including adverse event management, regulatory reporting, and compliance assurance, tailored to meet global and local regulatory standards seamlessly.

In addition to pharmacovigilance services, PharmaSoft provides regulatory affairs support, with a dedicated team of experts ensuring regulatory adherence.
Recognizing the pivotal role of technology in operational efficiency and business growth, PharmaSoft delivers innovative software solutions, such as a sophisticated pharmacovigilance database (PharmaBASE) and customized software applications (PharmaSEARCH). These solutions empower clients to achieve operational excellence, streamline workflows, and accelerate their journey towards success.
As a proud sponsor of the ISoP Annual Meeting Montreal, PharmaSoft remains committed to promoting excellence in pharmacovigilance.”

RxLogix

RxLogix is a global pharmacovigilance company providing cutting-edge software solutions designed to streamline pharmacovigilance processes, increase compliance, drive efficiency, productivity, excellence, and quality across the entire drug safety value chain through a combination of advanced technology and expert consulting. Our team of experts provide valuable insights and guidance to pharmacovigilance and risk management professionals, helping them navigate complex regulatory landscapes and achieve optimal outcomes.
We are located across Europe, US, and Japan with our Headquarter in Princeton, NJ.

YolaRx

YolaRx is a premier Consulting and Research Company specializing in Pharmacoepidemiology & Therapeutic Risk Management.

At YolaRx, our mission is to deliver the highest standards of research excellence and regulatory-grade expertise in pharmacovigilance analytics, background event rate analysis, benefit-risk assessment, systematic literature reviews, and the evaluation of effectiveness of risk minimization measures. We pride ourselves on supporting our clients with cutting-edge technology solutions that promote patient safety and drive optimal product outcomes. As a proud sponsor of this conference, YolaRx is excited to share our knowledge and actively contribute to the global advancement of pharmacovigilance and therapeutic risk management.

Vitrana

Vitrana is a market leading Drug Safety/Pharmacovigilance technology solution and services provider.

Vitrana top in the market PV solution platform (HiLIT PV) has been utilized by principal life sciences organizations since 2016. HiLIT PV is used by our clients for global intake, data quality, medical review, regional submission, reporting compliance and analysis, while providing integrated security and privacy along central safety systems.

Vitrana Services Consulting and Managed Services have delivered over 100 successful go-lives for our customers since 2014, including Argus and Argus J implementations, Argus upgrades, Safety Data Migrations, Safety Systems Support, Hosting and Managed Services, and Safety Helpdesk services.

Innovigilance

Media Partners

Women In Bio in general

Women In Bio in general (womeninbio.org)

Women In Bio is an organization of professionals committed to promoting careers, leadership, and entrepreneurship for life sciences professionals.

We are an organization of professionals from all career walks in the field of life sciences. We share the goal of enabling and empowering women to reach the highest levels of leadership, and — more importantly — to fulfill their own career aspirations.

Our members reflect the increasing spread of the life sciences. We belong to biotech and pharma companies, universities and institutes, law and accounting firms, marketing and PR firms, CROs, and CMOs. Many of our members are entrepreneurs, and a focus on entrepreneurship has remained core to WIB’s mission.The WIB Network expands far and wide across North America.

WIB’s primary focus is to provide women-to-women mentorship and leadership support through all stages of career development

from Bench to Boardroom
from Academia to Industry
from First Job to Last
from Idea to Entrepreneur

WIB-Greater Montreal
(https://community.womeninbio.org/clubs/view/wib-greater-montreal):

Founded in 2012

Le bureau montréalais de Femmes en bio souhaite rassembler les professionnelles de tout le Québec œuvrant dans divers secteurs liés aux biotechnologies. Les professionnelles des entreprises, les entrepreneures et les chercheures des secteurs privé, public et universitaire ainsi que les étudiantes sont invitées à devenir membres de Femmes en bio et à profiter des ressources offertes par l’organisme : réseautage, partage de connaissances et d’expertise, échange d’information sur les toutes dernières innovations et perspectives dans les domaines pharmaceutiques, biotechnologiques et des équipements médicaux.

The WIB-Greater Montreal Chapter seeks to bring together professionals from across Quebec with bio-related interests in diverse sectors. Business professionals, entrepreneurs and scientists from the private sector, government institutions, and academia are invited to join and benefit from WIB’s many resources which include networking, sharing insights and innovations, and learning about the latest developments, and opportunities within the pharmaceutical, biotechnology, and medical devices industries.

RAPS LNG Quebec

RAPS LNG Quebec is a regulatory affairs local network of pharmaceutical professionals in Quebec.

Pharma Now

pharmanow.live

Springer Nature

Springer Nature advances discovery by publishing robust and insightful research, supporting the development of new areas of knowledge, making ideas and information accessible around the world, and leading the way on open access.

Key to this is our ability to provide the best possible service to the whole research community.

Springer Nature’s catalog offers a wide range of products and services, including AdisInsight Safety which equips you with the essential tools to seamlessly manage your in-house PV literature monitoring. Our cutting-edge platform empowers you to efficiently monitor Individual Case Safety Reports (ICSRs) for adverse events and special situations. Plus, you can stay up to date with the latest drug safety news, ensuring that your PV processes remain robust and compliant. And what’s more important, AdisInsight Safety covers all pharmaceutical products.

You can rely on Springer Nature’s extensive knowledge and expertise, earned over 40 years as an industry leader. Our experience gives us a unique perspective on the challenges you face today, helping you see the world of drug development more clearly.