Inspections, Human Medicines Pharmacovigilance and Committees Division Inspections, Human Medicines Pharmacovigilance and Committees Division Fergus Sweeney Committees & Inspections Department Anabela Luis de Lima Marçal
Pharmacovigilance & Epidemiology Department Peter Arlett *
Scientific Committees Secretariat Thorsten Olski
Signal & Incident Management Georgy Genov
Experts & Declarations of Interests Management Luc Van Santvliet
Surveillance & Epidemiology Xavier Kurz
Manufacturing & Quality Compliance Brendan Cuddy
Clinical & Non-clinical Compliance Ana Rodriguez Sanchez Beato
Key: Divisions Departments Services / Offices Other organisational entities
Parallel Distribution & Certificates TBD
Italic Interim appointment *
Georgy Genov is acting as ad interim Head of Department Pharmacovigilance and Epidemiology during Peter Arlett's leave from 1 December 2016
Apr 10, 2017 - lifecycle. 2. Pharmacovigilance processes. 3. EU Network projects on .... 2016, it was clear that, while the service was improving, there was still ...
Jun 30, 2014 - Effective date: 17/10/2016 ...... This software is used for tracking the ... regulatory authorities and pharmaceutical companies in the EU.
Jun 6, 2017 - Can I receive the invoice by email? .... additional e-mail address or any other contact point other than the QPPV provided in 'Article 57.
Feb 16, 2017 - monitoring of several centrally authorised products ..... regulatory tools within the EU that are ... Following to this, a Rapid alert was circulated.
Aug 2, 2017 - ... EudraVigilance system to the new one, a 10 business day downtime is re- quired ... tions have now been added for initial testing of software/system .... qualified persons for pharmacovigilance (QPPVs) and companies' man-.
Jun 30, 2014 - BCP = Business continuity plan, IMP = incident management plan. .... quality management (including all EMA policies, standard operating .... completion of the pharmacovigilance task, by means of a one-way communication.
Jun 6, 2017 - Is it possible to estimate the fee to be paid by a marketing authorisation holder involved in an EU PSUR ..... Can I receive the invoice by email?
Cal/OSHA inspectors make unannounced visits to make sure that the UCI campus .... safe handling procedures and pyrophorics safety video (available online)?.
Apr 12, 2016 - be the duty of all school caretakers to keep the boiler rooms free ... In case of defect, the caretaker will notify the Service Desk, and also advise.
Mar 8, 2018 - Treatment of uterine fibroids. Haematology. New medicines authorised. ⢠Adynovi (rurioctocog alfa pegol). Treatment and prevention of bleeding in patients with haemophilia A. New information on authorised medicines. ⢠Feraccru (ferr
Treatment of cystine crystal deposits in the eye. New information on authorised medicines. Lucentis (ranibizumab) - change in indication. Treatment of visual ...
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The new EudraVigilance system and the electronic reporting of individual case ... the ISO/ICH E2B(R3) format: hands-on training course - October 2017 ... granted a conditional marketing authorisation on the basis of less complete clinical data ...
Apr 17, 2018 - 10:25 2.3 How are real-world evidence and patient registries used in benefit-risk evaluation to support early access to medicines. For information J. Moseley (EMA). 10:50 Coffee Break. 11:10 â¢. Discussion points. â Identify points
For a list of RSS readers please refer to our RSS guide and follow the instructions .... WEB-RADR workshop report: mobile technologies and social media as.
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PCWP and HCPWP joint meeting - Sept 2016 - meeting documents. ⢠Workshop on identifying opportunities for 'big data' in medicines development and ...
Used for the management of hypovolaemia (low blood volume) caused by acute (sudden) blood loss .... EMA's Business Continuity Plan for Brexit published.
RSS feeds you need one of the following: a modern web browser; a web-based news reader or a ... Withdrawal of applications for new medicines .... fifth annual regulatory conference on optimising the development of advanced therapies to.
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Key information for patients, consumers and healthcare professionals. Published monthly by the European Medicines Agency. An agency of the European Union. HUMAN MEDICINES. HIGHLIGHTS. Issue 107. February 2018. This newsletter is addressed primarily t