1. EU eCTD and NeeS validation: survey of industry and agency experience

As part of preparation for a presentation at the recent Visiongain London eCTD Summit, iRegulatory conducted some research on experience with eCTD and NeeS validation in the EU (from both the industry and agency perspectives). This article provides a summary of our findings, together with a commentary on the role of validation in overall submission quality management.

Wednesday, 26 May 2010 | 986 hits |  E-mail

2. Just how are companies producing NeeS submissions?

The most recent Heads of Agencies report on the uptake of electronic submissions in the EU (for the 6 months up to end June 2009) demonstrated a very clear pattern with regard to e-submission usage and formats:

Friday, 30 April 2010 | 706 hits |  E-mail

3. PIM - where next?

Article on PIM, the EMA's data exchange standard for pharmaceutical product information

Wednesday, 31 March 2010 | 1108 hits |  E-mail

4. eCTD in MRP and DCP: a review of the updated CMDh best practice guide

The Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) has published a new version of its best practice guide on the use of eCTD in the mutual recognition (MRP) and decentralised (DCP) procedures. This article provides a concise review of the updated guide, together with a commentary on implications for uptake of eCTD in MRP and DCP.

Friday, 26 February 2010 | 1991 hits |  E-mail

5. PIM to make our lives as regulatory professionals easier

At iRegulatory, experience with two separate projects this month has highlighted the promise of PIM to make our lives as regulatory professionals easier in the future, and achieve savings in terms of time and resource.

Thursday, 18 February 2010 | 1368 hits |  E-mail

6. Regulation of Advanced Therapies

Advanced therapy medicinal products (ATMP) differ from conventional medicines in that they are based on genes and cells. Whilst promising a wealth of opportunities in the treatment of human disease, this is a complex and rapidly changing area...

Thursday, 18 February 2010 | 923 hits |  E-mail

7. Electronic submissions: recent developments

There have been a number of developments within the last month that indicate that the pace of the transition from paper to electronic submissions is continuing to accelerate. This article provides a concise review of recent news.

Thursday, 18 February 2010 | 1206 hits |  E-mail

8. PIM for Electronic Submission of Product Information

PIM is a data exchange standard from the EMEA for the electronic submission and exchange in XML format of product information, including the Summary of Product Characteristics (SPC), Patient Information Leaflet (PIL) and package labelling.

Thursday, 18 February 2010 | 1185 hits |  E-mail

9. PIM for Electronic Submission of Product Information - Part Two

The implementation of PIM is associated with significant challenges, as discussed below.

Thursday, 18 February 2010 | 1039 hits |  E-mail

10. Version 1.4 of the EU Module 1 specification

The EMEA have published a new version of the EU Module 1 specification (v1.4). We take a closer look at the changes...

Thursday, 18 February 2010 | 1036 hits |  E-mail

11. eCTD Publishing: The case for Outsourcing

The shift from paper submissions to electronic submissions in recent years has been accompanied by corresponding changes in business processes. Electronic submission publishing requires a greater level of skill and experience than paper compilation, and the switch to electronic submissions has resulted in the emergence of a new type of specialist within regulatory affairs the submission publisher...

Thursday, 18 February 2010 | 876 hits |  E-mail

12. TIGes guidance for Industry on eCTD submissions

The EU Telematic Implementation Group (TIGes) has now published draft Guidance for Industry on Providing Regulatory Information in Electronic Format: eCTD electronic Submissions. In this feature article, Dr Martin Moxham reviews this new guidance and provides a commentary on its implications.

Thursday, 18 February 2010 | 1155 hits |  E-mail