Applications

Training

Basic and advanced staff training …
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eCTD Manager

We prepare and submit your eCTD, VET eSubmissions and NeeS applications
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RUT

IT-Tool for Readability User Testing
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Auditing

of your pharmaceutical activities in a GXP environment
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Training - MPCA  ACADEMY

The M.P.C.A. International BV staff is qualified in RA, RIP, PV/ LCP, RP for GDP and QP for GMP. We also train your staff in these fields.

As legal accredited Responsibles for Information and Publicity (RIP) we provide RIP training for your staff of representatives.

Since 2011, several level trainings on "Pharmacovigilance and Adverse Event Awareness" were added to our services.

Your colleagues working in a qualified GDP environment need to be trained on a yearly basis. We provide training with GDP certificate. Recently we added FMD training for warehousing staff.

In GMP you may select the courses according to the internal needs of your company and combine them to suit your needs.

Training to EU and BENELUX legislation and guidelines is a much sought-after application.

Training is given in English, Dutch, French and German.

eCTD Manager by Extedo

M.P.C.A. International BV offers CTD to eCTD conversion and subsequent submissions in eCTD format or NeeS format (Non eCTD electronic Submissions). For eCTD we use the eCTD Manager tools of Extedo.

For more information about our way of working, timelines and prices, please contact us at info@mpca.be.

eCTD, VET eSubmissions and NeeS Applications by M.P.C.A. International BV 

  • eCTD is a CTD or common technical document in electronic format. Abbreviated as eCTD.

The Common Technical Document (CTD) describes the organisation of modules, sections and documents to be used by an Applicant for a Marketing Authorisation for a medicinal product for human use agreed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).

The electronic Common technical Document (eCTD) allows for the electronic submission of the Common Technical Document (CTD) from applicant to regulator.

While the table of content is consistent with the harmonised CTD, the eCTD also provides a harmonised technical solution to implementing the CTD electronically for saleread this articlethe best replica watches in the worlds21 phone case. In other words, an eCTD is the submission of PDF documents, stored in the eCTD directory structure, accessed through the XML backbone and with the files integrity guaranteed by the MD5 Checksum.

The eCTD format is mandatory to be used for all submission types related to Marketing Authorisation for products within all EU procedures (i.e. Centralised, Decentralised and Mutual Recognition Procedures). In accordance with the eSubmission Roadmap, mandatory eCTD format is also stepwise introduced for National Procedures.

  • VET eSubmissions

The Veterinary Harmonisation Group (VHG) is a subgroup of the eSubmission expert group and is made up of representatives from National Competent Authorities, the EMA and Industry. Its objective is to develop and implement standards for the submission of electronic information in the context of European veterinary medicines approval procedures.

  • NeeS or Non eCTD electronic Submission

eCTD is mandatory however there are a small number of exceptions where NeeS submission is still possible.

Readability User Testing

Readability testing of Patient Information Leaflets (PIL) is also referred to as Readability User Testing (RUT). The report that is generated leads to provide a validated Module 1.3.4 in the e-CTD (Common Technical Document or EU registration file).

“Reading the information on a leaflet is not the same as understanding it.”
The most important part of our work is to ensure that people understand how to use a medicinal drug safely and correctly.

M.P.C.A. International BV has been involved with readability testing since the beginning of the requirement in November 2005 and has developed a validated webtool to facilitate the work and handle a databank of readers. Please search the web for www.MPCA-leesbaarheid.be

Our offer:

  • PIL reformatting to current QRD;
  • review of the Word text (based on 20 or twice times 10 interviews) for optimal readability;
  • mockup handling;
  • quick turnaround in as little as 48 hours within a period of 4 weeks;
  • reports according to the guidelines, ready for submission to these authorities;
  • cost-effective solution (very competitive costs);
  • 100% approvals to date;
  • proven effective test methods according to various guidelines, including the EMA (EU), MHRA (UK), CBG-MEB (NL), FAGG (Belgium), ANSM (France), BfArM and PEI (Germany), AIFA (Italy).

For more information or a quotation, please send us an email to info@mpca.be, or give us a call on +32 476 66 47 05.

M.P.C.A. International BV has guided over 250 package leaflets to EU submission. We are well known for our state-of-the-art quality and flexibility.

Furthermore, we have quite a track record concerning our success rate: 100% of our PIL user tests have been validated by various authorities. We continue to receive sincere compliments from the authorities on the quality of our extended reports.

Please note: During Corona Pandemic
Due to the Corona safety requirements, the upcoming readability test can also be conducted online.
To continue our tests, we use Teams with image and sound to secure “social distancing”. You will receive the package leaflet by post (Priority). Payments are made through online bank applications.
As soon as possible, of course, after the Corona pandemic, we will continue our RUT in the old way in which we again interview each reader in person.

Performed in accordance with the following Guidelines:
Directive 2001/83/EC as amended Directive 2004/27/EC (human) Article 59(3) and 61(1) European Commission, Eudralex Vol 2, May 2006 - Guidance concerning consultations with target patient groups for the package leaflet. (https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-2_en)

“The package leaflet shall reflect the results of consultations with target patient groups to ensure that it is legible, clear and easy to use.”

References:

Auditing

In order to improve a regulated quality system, an audit process is required.

Competent authorities increasingly expect pharmaceutical companies to regularly audit their suppliers and service providers as well as their own internal organisation.

This involves both internal and external audits:

  • Internal audits, including supplier audits of the full range of products and services purchased, are tools that ensure continuous improvement to the daily core-business activities.
  • External audits, like customer audits or audits by the government, are tools to verify compliance or agreement between business processes on the one hand and procedures and regulations on the other.

M.P.C.A. International BV offers consultancy advice and application services and support in order to allow an audit to be carried out successfully. Every audit is followed by a detailed report, whereafter help is offered to establish a CAPA-plan. The follow-up activities enable you to maintain on the audit calendar of your business .

M.P.C.A. International BV is experienced in the performance of Yearly Management Reviews of your pharmaceutical business.