1 February 2017

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

Inspections, Human Medicines Pharmacovigilance and Committees ...

Brendan Cuddy. Clinical. & Non-clinical Compliance. Ana Rodriguez. Sanchez Beato. Parallel Distribution. & Certificates. TBD. Signal & Incident. Management.

101KB Sizes 0 Downloads 239 Views

Recommend Documents

What's new in pharmacovigilance? - European Medicines Agency
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 ...

EMA pharmacovigilance system manual - European Medicines Agency
Jun 30, 2014 - Effective date: 17/10/2016 ...... This software is used for tracking the ... regulatory authorities and pharmaceutical companies in the EU.

Pharmacovigilance Fees Questions & Answers - European Medicines ...
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.

Veterinary pharmacovigilance 2016 - European Medicines Agency
Feb 16, 2017 - monitoring of several centrally authorised products ..... regulatory tools within the EU that are ... Following to this, a Rapid alert was circulated.

What's new in Pharmacovigilance? - European Medicines Agency
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-.

EMA pharmacovigilance system manual - European Medicines Agency
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.

Pharmacovigilance Fees Questions & Answers - European Medicines ...
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 Inspections - UCI
Cal/OSHA inspectors make unannounced visits to make sure that the UCI campus .... safe handling procedures and pyrophorics safety video (available online)?.

buildings and grounds inspections
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.

Human Medicines Highlights Newsletter - European Medicines Agency
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

Human Medicines Highlights Newsletter - European Medicines Agency
Treatment of cystine crystal deposits in the eye. New information on authorised medicines. Lucentis (ranibizumab) - change in indication. Treatment of visual ...

Human medicines highlights - February 2017 - European Medicines ...
To receive each new issue of the newsletter, please click here RSS feeds, choose 'Human medicines · highlights newsletter' and then click on 'Subscribe to this ...

Human Medicines Highlights Newsletter - European Medicines Agency
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 ...

EMA Human Scientific Committees' Working Parties with Patients' and ...
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 •. Discussion points. − Identify points

Human medicines highlights - March 2017 - European Medicines ...
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.

Human medicines highlights - January 2017 - European Medicines ...
RSS feeds you need one of the following: a modern web browser; a web-based news reader or a desktop news reader. For a list of RSS readers please refer to ...

Human medicines highlights newsletter - European Medicines Agency
PCWP and HCPWP joint meeting - Sept 2016 - meeting documents. • Workshop on identifying opportunities for 'big data' in medicines development and ...

Human Medicines Highlights Newsletter - European Medicines Agency
Used for the management of hypovolaemia (low blood volume) caused by acute (sudden) blood loss .... EMA's Business Continuity Plan for Brexit published.

Human Medicines Highlights Newsletter - European Medicines Agency
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.

Human Medicines Highlights Newsletter - European Medicines Agency
Implant used to help new bone develop in patients with spinal disc problems and leg fractures .... E-mail [email protected] Website www.ema.europa.eu.

Human Medicines Highlights Newsletter - European Medicines Agency
RSS feeds you need one of the following: a modern web browser; a web-based news reader or a desktop news reader. For a list of RSS readers please refer to ...

Human medicines highlights - February 2018 - European Medicines ...
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

Human Medicines Research and Development Support Division
Human Medicines Research & Development. Support Division. Scientific. Advice. Spiridon Vamvakas. Paediatric Medicines. Ralph Bax. Orphan Medicines.

2017 Committees and Responsibilities.pdf
John Whimpress Bulletin. Kevin Prosser Sam Cozens Ron Jericho. Stephen Walker. Sam Cozens. Ron Jericho Club Audio System. Management. Social Media.