Category Archives: userBridge Presentations

This category shows articles about presentations held at userBridge conferences.

Which comes first: Regulatory Information Management (RIM) or ISO Identification of Medicinal Products (IDMP)?

The presentation “Which comes first: Regulatory Information Management (RIM) or ISO Identification of Medicinal Products (IDMP)?” was given by Deborah Cooper, Vice President Consulting at GENPACT Pharmalink, at LORENZ userBridge.15 in Vienna, Austria.

In her presentation, Deborah Cooper discussed the impact of the ISO IDMP Implementation Roadmap on RIM strategies and presented the GENPACT IDMP readiness assessment for customers.

The ISO IDMP Standard and Iterative Implementation Roadmap
Based on EU Commission Implementing Regulation No 520/2012 (articles 25 and 26), the EMA is in the process of implementing the five ISO standards for IDMP (ISO 11238, 11239, 11240, 11615 and 11616). This should simplify the exchange of information between regulatory authorities, enhancing the interoperability of systems at EU level and internationally. The European Commission, the European Union (EU) Network Data Board and the EU ISO IDMP Task Force have endorsed a phased implementation of the ISO IDMP standards.

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The NDA Marriage – Complementing Regulatory Strategies with Technical Solutions

Jillian Lee

The presentation “The NDA Marriage” was given by Jillian Lee, Senior Global Submission Specialist at Bayer Health Care AG, at LORENZ userBridge.14 in Milan, Italy.

In her presentation, Jillian Lee outlined an approach for concurrent submission applications.

Background: sequential regulatory requirements
Bayer’s mission is “Science For A Better Life”. For the pharmaceuticals division, this means – making available safe, effective, and potential life-saving options to patients as quickly as possible. Currently however, technical barriers prevent the submission of a NEW indication for a drug while the first indication is still in the initial approval process with health agencies.

So a solution is needed to reduce the overall review timelines and potentially help in “fast-tracking” approvals. The answer is simple, although technically complex: enable concurrent applications. Continue reading

eSubmissions in Australia

Kent  BriggsThe presentation “eSubmissions in Australia” was given by Kent Briggs, Lead Senior Consultant at LORENZ Life Sciences Group, at LORENZ userBridge.14 in Milan, Italy.

In September, I presented the status of eSubmissions in Australia on behalf of the TGA. Since then, the TGA has been busy ensuring a quick and successful implementation of eCTD and setting the foundation for electronic review across all formats.

From the beginning, the TGA “pilot” was kept open allowing anyone to take part that expressed interest. As a result, the first eCTD applications began arriving in October and the first lifecycle sequences in the early parts of 2015.

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Moving from low parcel content to no parcel content

Beate KienzlerThe presentation “Using the EMA Gateway & CESP for Electronic Submissions” was given by Beate Kienzler, Head of Regulatory Affairs at Dr. Regenold GmbH, at LORENZ userBridge.14 in Milan, Italy.

For some years now, electronic submission gateways and how to use them have been a hot topic of discussion in the Regulatory Affairs world. Following the move from paper to electronic submission formats, gateways can be considered the next step in an evolution. As Beate Kienzler put it during her presentation at the LORENZ userBridge.14 conference in Milan, “we are moving from low parcel content to no parcel content”. Continue reading

Strategies for making the Business Case for IDMP

Andrew MarrThe presentation “Implementation of IDMP is coming: Strategies for making the Business Case” was given by Dr. Andrew Marr, Managing Director of Marr Consultancy Ltd, at LORENZ userBridge.14 in Milan, Italy.

Dr. Andrew Marr is a well-known as a compelling speaker at userBridge conferences. Sharing more than 30 years of experience in regulatory affairs and regulatory operations, he acts as a leading consultant on xEVMPD and IDMP (Identification of Medicinal Product), and is also closely involved in the development of the ISO IDMP standard and guidance and was heavily involved in the current eCTD specifications. Continue reading

Preparing for First eCTD in ASEAN

Teerapong Cheepchol

The presentation “Preparing for First eCTD in ASEAN” was given by Teerapong Cheepchol (Jack), Deputy Managing Director of Factorytalk Co., Ltd. in Bangkok, Thailand, at LORENZ userBridge.14 in Milan, Italy.

Mr. Cheepchol (or Jack as he is known here at LORENZ), who also presented at userBridge.13 last year in Budapest, Hungary, used the userBridge.14 conference to present an update on what was happening in Thailand with regards to the eCTD and electronic submission in general. What might not be known by most people is that ASEAN uses what is called the ACTD (ASEAN CTD) structure or format, which differs in structure when compared to the CTD but still contains more or less the same information as the CTD. Continue reading