My Ipsen
Name 3 TAs Ipsen is working on
Neurology / Oncology / Endocrinology / Rare diseases
PDCS
Patient Data Collection Systems
MAH
Marketing Authorization Holder
Pharmacovigilance
Science and activities relating to the detection, assessment, understanding, and prevention of adverse effects and other drug-related safety problems.
ADR vs AESI
ADR
A response to an Ipsen product which is noxious and unintended. Response in this context means that a causal relationship between an Ipsen product and an adverse event (AE) is at least a reasonable possibility. ADRs may arise from use of the product within or outside the terms of the marketing authorisation or from occupational exposure. Conditions of use outside the marketing authorisation include off-label use, overdose, misuse, abuse and medication errors.
AESI
As per CIOMS VII, an adverse event of special interest (serious or non-serious) is one of scientific and medical concern specific to the sponsor’s product, for which ongoing monitoring and rapid communication by the investigator to the sponsor could be appropriate. Such an event might require further investigation in order to characterise and understand it. Depending on the nature of the event, rapid communication by the trial sponsor to other parties (e.g., regulators) might also be warranted.
Day 0
I am the date safety report was initially received by Ipsen employee or any Ipsen third party.
GPS PMO Head
Maud Gonnet
Annual global revenue
3.5 Billion USD
EAP
Early Access Program
BCP
Business Continuity plan
Healthcare Professional (HCP)
For the purposes of reporting suspected adverse reactions, HCPs are defined as medically qualified persons, such as physicians, dentists, pharmacists, nurses and coroners or as otherwise specified by local regulations.
Abuse vs Misuse
Abuse
Abuse corresponds to the persistent or sporadic, intentional excessive and non therapeutic use by a patient or consumer of a medicinal product, which is accompanied by harmful physical or psychological effects
Misuse
Misuse refers to situations where medicinal product is intentionally and inappropriately used for therapeutic purpose by a patient or consumer other than as prescribed and non in accordance with terms of the MA.
GPS Reginal Team
I actively support or ensure appropriate support to the Ipsen Affiliate LPVMs, to deliver the Ipsen Pharmacovigilance System, and associated quality system
I provide support and expertise for all vigilance staff and activities in affiliates ensuring that processes are comprehensive, embedded in the cross-functional and global-local environment
Audit inspection point of contact
Marina Lengsavath / GPS audit and inspection mail box
Founded in year
1929
GAL
Global PV Agreement List
IME
Important Medical Event
PSMF
A detailed description of the PV system used by the MAH with respect to one or more authorised medicinal products.
It includes the body of the text as well as annexes.
Intercepted medication error vs Potential meciation error
Intercepted medication error
An intercepted medication error refers to the situation where medication error, which could have resulted in a potential adverse drug reaction has occurred but was prevented from reaching the patient or consumer. The intervention has prevented actual harm being caused to the patient.
Potential medication error
A potential medication error refers to all possible mistakes in a prescribing, storing, dispensing, preparation for administration or administration of a medicinal product by all persons who are involved in the medication process and may lead to a medication error with or without harm. It is the recognition of circumstances that could lead to a medication error and may or may not involve a patient.
Product Safety Team/Benefit Risk Team
I am a subset of the Asset Team, core members being those how directly handle safety information. Team is assessing new signals and risks base on completed Safety Evaluation Report, defining Adverse Events of Special Interest, preparing Data Monitoring Committee meeting
RMP SME
Vittoria Lambertucci
Founder
Dr Henri Beaufour
APVAR
Affiliate Pharmacovigilance Agreement Report
IB
Investigator Brochure
Special Situations
- Exposure during pregnancy (maternal and paternal exposure)
- Exposure during breastfeeding
- Overdose
- Abuse
- Misuse
- Medication error/Intercepted medication error/Potential medication error
- Occupational exposure
- Lack of efficacy
- Off-label use
- Use in a pediatric or elderly population.
- Other SSs:
-Counterfeit/Falsified medicinal product only if the product has been administered
-Unexpected therapeutic benefit
-Suspected transmission of an infectious agent via a medicinal product
-Drug interaction
-Drug dependence
-Underdose
EAP vs PSP
EAP
An Ipsen Product Access Request from a Physician with the product access managed via a program.
There are several different terms used for early access programs around the world including Compassionate Use Program (CUP), Expanded Access Program (EAP), Patient Access Program (PAP), Special Access Program (SAP), Special Access Scheme (SAS).
PSP
Structured programs which interact with individual patients who are eligible for or are being prescribed an Ipsen registered and commercialized product within the approved label. These programs can be conducted by Ipsen either with or without service providers.
Registered product with a set price to sell (private and/or reimbursed)
PSPs are non-promotional and are offered for the benefit of the patients. Key objectives are to:
Monthly Affiliate Report
I am the tool provided and maintained by GPS and filled by the LPVM as required, with the purpose of sharing essential vigilance information from the affiliate for GPS oversight. I reside in GPS Document Portal.
Somatuline GPS Scientist
Stéphanie Costa Dasilva
Ipsen mission statement
Together. For Patients & Society.
DORF
Database Output Request Form
PSP
Patient Support Program
aRMMs
Activities or tools developed by the MAA/MAH and designed to ensure the safe and appropriate use of a product in circumstances where routine risk minimisation measures alone are deemed to be insufficient to address a particular safety concern. These include but are not limited to educational materials/programmes aimed at the Patient and/or Prescriber, and communications to healthcare professionals.
ATOLS vs CoManDO
ATOLS
“Approval Tool for prOgrams and study proposaLS”
An electronic Document Management System (eDMS) designed for the collaborative review and approval of study and program proposals managed by GMA and LMA. The system is also used for the management of EAP, PSP, NPUR and MRP and serves as a document repository for Grants & Donations.
CoManDo
Collaborative Management of Documents
Electronic Document Management System (eDMS) used for the review and approval of promotional and non-promotional materials, and for the repository of Digital Media documents.
Safety Clause
I define the PV responsibilities of both Parties who signed the Agreement either at global or local levels. I am either included in the body or as an Annex of the Main Agreement with a Commercial Partner e.g. Distributor/Wholesalers Agreements, Promotional Agreements.
GPS Regional Lead for Americas
Allison Concannon
Name 3 companies Ipsen acquired in recent past
Clementia Pharmaceuticals – Palovarotene
Epizyme - Tazverik
Albireo- Bylvay
EGRB
Evidence Generation Review Board
AESI
Adverse Event of Special Interest
Post-authorisation safety study (PASS)
Any study relating to an authorised medicinal product conducted with the aim of identifying, characterising or quantifying a safety hazard, confirming the safety profile of the medicinal product, or of measuring the effectiveness of risk management measures [DIR 2001/83/EC Art 1(15)]. A post-authorisation safety study may be an interventional clinical trial or may follow an observational, noninterventional study design.
Secondary MRP vs Syndicated MRP
Secondary MRP
Secondary Market Research Programme whose data that was already collected for one purpose is then re‑analysed for another purpose
Syndicated MRP
Market Research Programme that is shared (both the findings and the costs) by a number of clients. However the market research agency owns the data
Development Risk Management Plan (dRMP)
I am the internal repository document started before First in Human and up to Marketing Authorization Application describing how risks (theoretical, potential and identified) in relation with on-target and off-target engagement of the product or of its main metabolites are detected, monitored, characterized and minimized.
Dysport Safety Asset Lead
Sarah Harding
Mention any 3 out of 5 Ipsen ways of being
We lead with purpose
We learn & share every day
We drive for success
We trust each other
We own the outcome
SER
Safety Evaluation Report
Signal
Information arising from one or multiple sources, including observations and experiments, which suggests a new potentially causal association, or a new aspect of a known association between an intervention and an event or set of related events, either adverse or beneficial, that is judged to be of sufficient likelihood to justify verificatory action (European Medicines Agency, GVP Annex I)
GPS Compliance team vs PV Qulaity Assurance team
GPS Compliance team
Team internal to GPS that is coordinating KPI monitoring, GPS training, PSMF Updates, Audits & Inspections GPS activities, Deviations, Change control
PV Quality Assurance
Team out of GPS supporting GPS from a quality assurance perspective in development and maintenance of the PV Quality Management System* for continuous improvement and identification and control of process quality risks
*QA review of Critical and major Deviations, of Quality Documents, of Change Control, QA oversight management and coordination of PV inspections and external audits within the Company
Debiopharm
I am the key license partner of Ipsen for triptorelin.
Bylvay GPS Physician
Douglas Silveira