Within our PV organisation, the QPPV office and the global PV infrastructure co-exist, creating a unique opportunity for seamlessly integrated and unified global PV system oversight by the QPPV.

Discover a range of associated services, including:

– European Union (EU) Qualified Person for Pharmacovigilance (EU/EEA QPPV) and Deputy

– United Kingdom QPPV (UK QPPV) and the national contact persons for PV in the UK

– Eurasian Economic Union QPPV (EAEU QPPV) and deputies

– Local Pharmacovigilance Officers (LPPVs, Local QPPVs, Local Safety Officers, LSRs)       across Europe, Russia & CIS and MENA

– Teams for medical counselling and Safety physicians

– Pharmacovigilance System Master File (PSMF) and regional PV System Sub-Files (PSSF)

Pharmacovigilance requires local coverage and compliance with various local regulatory requirements. Marketing authorisation holders must ensure an adequate local pharmacovigilance function in different countries. At All Life Sciences, we support marketing authorisation holders in establishing local pharmacovigilance systems and provide Local Pharmacovigilance Representatives (LPPVs, Local QPPVs, LSRs) for continuous local pharmacovigilance management across Europe (EU/EEA), Russia & CIS and MENA. Our unified governance model consolidates country-level operations into a seamless, integrated regional system that provides clients with a single interface for oversight, compliance monitoring and consistent global service delivery.

Diverse service offering:

– Provision of Local Pharmacovigilance Representatives (LPPV / Local QPPV / LSR) and deputies

– Creation and maintenance of local PV systems, including local PSMF, local SOPs, etc.

– Ensuring 24/7 availability, if required

– Local literature screening for pharmacovigilance

– Processing of safety reports – receipt, processing, reporting, follow-up

– Submission of domestic and foreign ICSRs to local competent authorities, if required

– Local implementation of aRMMs (educational materials, DHPC communication)

– Monitoring of local PV legislation with constant updates for the client

– PV training for the employees of the client’s local subsidiaries or distributors

– Submission of aggregated safety reports (PSURs) and risk management plans (RMPs) where required

– Handling requests and inspections from the relevant local authorities

Our weekly literature screening ensures proactive pharmacovigilance monitoring. Our experts continuously review and evaluate the identified publications and ensure that the documentation is ready for review. Our local literature screening in the EU and UK includes comprehensive journal lists, including electronic journals, local databases and paper editions of journals with local subscriptions. Our local PV experts are fluent in the local language and have timely access to the relevant publications. In addition, we monitor global databases (PubMed, Springer, Embase) and monitor the active substances in the MLM (Medical Literature Monitoring) list of the European Medicines Agency (EMA).

Discover a variety of services, including;

– Local (non-indexed) literature screening at country level in the EU and UK

– Retrospective local literature review (as part of CAPA or Quality Check)

– Global (indexed) literature screening in PubMed / Medline and Springer

– Global and local ad hoc literature searches for signal detection and PSURs / PBRERs

– Weekly EudraVigilance (MLM) checks using the ICSR export module

All Life Sciences ensures that its customers are always one step ahead of regulatory changes and requirements. Our PV Regulatory Intelligence Services cover centralised monitoring of global requirements (EMA, ICH) and use local PV infrastructure and LPPVs to collect regional information from national competent authorities. We communicate updates promptly and provide summaries, impact assessments and necessary actions. Our PV information service is tailored to the needs of our customers in terms of territories, content and frequency and is a proactive compliance measure.

Discover a range of services including:

– PV Regulatory Intelligence on new PV requirements, changes and developments

– Regional regulatory information on pharmacovigilance (EMA, MHRA, FDA, ICH, WHO, etc.)

– Local regulatory information (national / country-specific updates on PV requirements)

– Information on local reporting obligations (ICSRs, SUSARs/SAEs, PSURs, DSURs, etc.)

– Local Person for Pharmacovigilance (LPPV) requirements

Explore a variety of services, including:

– Local (non-indexed) literature screening at country level in EU & UK, CIS, MENA

– Retrospective local literature review (as part of CAPA or Quality Check)

– Global (indexed) literature screening in PubMed / Medline and Embase

– Global and local ad hoc literature searches for signal detection and PSURs / PBRERs

– Weekly EudraVigilance (MLM) checks using the ICSR export module

All Life Sciences, together with its partners, offers safety data processing and timely rapid and summary reports. Our team’s extensive experience in case management includes case intake, data entry, coding, medical review, follow-up and quality control. We are familiar with various safety databases such as Argus, ArisG,

Veeva Safety Vault. We support you in setting up, hosting and migrating databases. Our comprehensive monitoring of PV regulations ensures that our clients can proactively respond to changes in regulations and reporting requirements.

Case Processing and Medical Writing:

 E2B and CFR21 compliant validated security database management

 Processing and reporting of Individual Case Safety Reports (ICSRs)

 Processing of SAEs and other reportable events from clinical trials

 Medical review and medical evaluation

 Medical coding (MedDRA, WHODrug)

 Report writing

 Preparation and submission of periodic safety update reports (PSURs)

 Preparation and submission of development safety update reports (DSURs)

 Regulatory reporting (EudraVigilance, US FDA, local authorities)

Regulatory Intelligence:

 PV Regulatory Intelligence on new PV requirements, changes and developments

 Regional information on pharmacovigilance regulations (EMA, MHRA, FDA, ICH, WHO,

etc.)

 Local regulatory information (national / country-specific updates on PV requirements)

 Information on local reporting requirements (ICSRs, SUSARs/SAEs, PSURs,

DSURs, etc.)

 Local Person for Pharmacovigilance (LPPV) requirements

Literature Monitoring:

 Local (non-indexed) literature screening at country level in the EU & UK

 Retrospective local literature review

 Global (indexed) literature screening in PubMed / Medline / Springer and Embase

 Global & local ad hoc literature searches for signal detection and PSURs / PBRERs

 Weekly EudraVigilance (MLM) checks with the ICSR export module

Our clinical safety services cover a broad range of therapeutic areas and product classes, including small molecules, biologics, ATMPs and gene therapies. As a full-service external clinical safety organisation, we offer clinical trial sponsors and CROs flexibility, scalability and operational efficiency. With expertise in developing robust safety management plans, our team ensures high quality and accurate case processing, timely expedited and aggregated reporting, and database set-up.

Services Offered:

– Development of Safety Management Plans

– Regulatory information on country-specific reporting requirements

– Provision of a EudraVigilance (EV) responsible person

– Processing of SAEs and other reportable events

– Medical review, assessment and MedDRA coding

– Regulatory reporting (EudraVigilance, US FDA, local authorities)

– Report writing

– Preparation and submission of periodic safety reports

All Life Sciences provides 24/7/365 medical monitoring services and ongoing medical support for clinical trial sponsors, investigative sites and study teams. Our team of licenced physicians has extensive knowledge in various therapeutic areas that include small molecules, biologics and advanced therapy medicinal products. We provide strategic advice on trial design and ongoing clinical and medical monitoring at all stages of a clinical programme. Our medical monitoring services can be seamlessly integrated into our full-service clinical safety solution.

Services offered:

– Development of medical monitoring plans

– medical monitoring with 24/7 coverage

– Act as medical point of contact for investigators and sites

– Provide ongoing medical support for eligibility, questions or concerns

– Review of laboratory results

– Review of serious adverse events (SAEs) and safety information

– Causality assessment discussions

– Medical coding of SAEs and medications (MedDRA, WHO Drug Dictionary)

– Medical review of study documents and materials (protocols, CRF, data, lists, reports)

– Medical consultations