Regulatory Affairs Network

CEE & CIS CT Forum

Wednesday, 25 January 2012 00:00 Fleming Europe Business News - Events

5th annual CEE & CIS CT Forum

18-19^th April 2012, Vienna

The increasing demand for eligible study patient populations in order to prepare markets for new medicines as well as the need for more cost-efficient clinical development programs are the key reasons why the pharma industry is conducting clinical trials in the CEE and CIS region. However, there are a number of challenges that all industry stakeholders need to overcome in order to conduct clinically and commercially successful trials.

Quality and Process Excellence

Tuesday, 17 January 2012 17:00 Kakushin Group Business News - Events

Applying Quality and Process Excellence in Pharma

18 April 2012

Pharma Industry failes to keep up with other industries in terms of manufacturing efficiency and productivity, largely because of the cost and limitations involved in revalidating any process changed in the spirit of improvement. Once manufacturers confirm or validate their processes as compliant, they traditionally have been very reluctant to change them and introduce the innovation in the manufacturing processes. The simple fact is that pharmaceutical manufacturers, which historically have enjoyed consistently robust profit margins, have had little economic incentive to introduce change.
Applying Quality and Process Excellence in Pharma is a 1/2 day web-forum focused on Quality and Process Excellence.

Audit and Regulatory Inspection

Wednesday, 16 November 2011 09:26 EICCRP Business News - Events

PREPARING FOR AUDIT AND REGULATORY INSPECTIONS

Ensuring the Success of your Clinical Trials

Vienna, 16^th - 17^th February 2012.

Do audits and inspections affect your work? What do you do when the EMA or the FDA comes knocking? Are you absolutely confident that everyone is fully prepared? Every clinical trial is subject to audits as well as health authority inspections from time to time, verifying compliance with rigorous requirements that have in fact changed significantly over the last few years. In this MasterClass you will learn, develop and practice what you need, to be ready when the call comes, taking you through from the announcement to the end of the process.

We are cordially inviting you to join us for our next advanced MasterClass titled Preparing for Audit and Regulatory Inspection in Vienna on 16^th - 17^th February 2012. The event has been designed to allow plenty of opportunities for discussion and sharing best practice.

Attending you will:

• Understand how to prepare for EMA and FDA audits

• Learn how to plan for an audit or inspection including the use of appropriate checklists/EMEA inspection guidelines

• Know how to prepare for audit/inspection interviews

• Acquire a greater understanding of responding to the audit/inspection findings

•Improve your ability to carry out corrective and preventative action in response to inspection findings

About the course leader:

Laura Brown, PhD, MBA, Diploma Clinical Sciences is an independent QA and Training Consultant in the Pharmaceutical Industry and Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff. Laura has almost 20 years of experience in running clinical trials and clinical quality assurance in the pharmaceutical industry.

Join us and SAVE

Early Bird Discount until December 16^th

Incremental group discounts start from 2 persons!

For more information, detailed agenda and group discounts please contact us at: This e-mail address is being protected from spambots. You need JavaScript enabled to view it or visit our site at www.eiccrp.eu.

Cheaper vaccines for poor children

Thursday, 30 June 2011 11:09 Drug Information Association Business News - Press Release

Cheaper vaccines for children of Asia and Africa

GAVI (Global Vaccine and Immunization Alliance) summit in London last week surpassed the excpectations of the organizers.

Free eCTD Viewer

Friday, 06 May 2011 07:57 Mono Software Business News - Regulatory Affairs News

Looking for a free eCTD Viewer?

Release Announcement: FREE eCTD Viewer - Your eCTD Viewing Solution.

http://ectdoffice.com/release-announcement-free-ectd-viewer.aspx

Mono Software and PRS today announced the release of the FREE eCTD Office eCTD Viewer - stand-alone, super-fast, easy to use Windows desktop application for viewing and understanding the granularity and the lifecycle of electronic submissions prepared in the eCTD (Electronic Common Technical Document) format.

LORENZ Group at International Conference on Good Documentation Practice in Regulatory Procedures

Wednesday, 27 April 2011 13:50 Maja Barac Business News - General Gulielines

LORENZ Group at International Conference on Good Documentation Practice in Regulatory Procedures

Lorenz Group has been developing innovative software solutions for Life Sciences for more than 20 years and is major e-CTD provider for the EU, Japan and U.S.

Execution drug no more available in the USA?

Monday, 21 February 2011 14:31 Maja Barac Business News - Press Release

Execution drug no more available in the USA?

Sodium thiopental, main ingredient of lethal injection used for the execution in state prisons/penitentiaries in most of the USA states is going to be lacking in near future. The only manufacturer of this drug for the USA market which is authorized for the production by the FDA – company Hospira si slowly stopping the production.

DCP Slots at Malta

Tuesday, 08 February 2011 15:15 Zdravko Mauko Business News - Regulatory Affairs News

Malta as Reference Member State in the Decentralised Procedure

Since 2007 the Medicines Authority is accepting applications as Reference Member State in the Decentralised Procedure.

Until further notice, the applications considered will be those for solid oral dosage forms and oral solutions in accordance with article 10 of Directive 2001/83/EC, as amended.

To be able to consider such applications, some information is requested to enable the Medicines Authority to assess whether to accept the submission of an application for a Marketing Authorisation or not. The Request Form on the CMDh website should be filled in and sent to the Medicines Authority at least 6 months before the proposed submission date. The requests should be sent by e-mail directly to the CMDh (MRP/DCP) contact point with a copy to the e-mail address This e-mail address is being protected from spambots. You need JavaScript enabled to view it .

The slots for the 20 procedures planned for 2010 are all booked. A few procedures are on the waiting list should slots become available in case of cancellation by the applicants.

Currently the Medicines Authority is filling in slots for 2011 - 2012. Please send in the pre-submission forms in due time for consideration, at least six months before proposed submission date. Once you are given a slot, you are requested to inform the Medicines Authority immediately should you not be able for any reason to submit in the agreed timeline. The Medicines Authority should be informed in good time about any problems encountered that may lead to postponement or cancellation of the slot that is granted.

Information and guidance documents on the decentralised procedure can be found on the CMDh website.

Public assessment reports of products authorised with procedures where Malta is RMS are being made available on http://www.medicinesauthority.gov.mt/par.html

Information source: www.medicinesauthority.gov.mt

Banishment of unlicensed herbal remedies in the UK

Sunday, 16 January 2011 13:11 The Independent Business News - Regulatory Affairs News

Banishment of unlicensed herbal remedies in the UK

Thousands of patients in the UK facing the decision about the banning of more than 200 herbal products. For some, this decision is discriminatory and shameful. The same measures are planned for the rest of the EU in accordance with new directive from 2004 (part which concerns herbal products) - from 1 May 2011 all herbal products in the UK must be licensed or prescribed by a registered herb practitioner. This is connected with the concern over adverse events in these products.