30 November 2011

THE eCTD SUMMIT: Using Older PDF Versions

As mentioned in an earlier blog from Rahul Mistry, the FDA currently accepts PDF 1.4 and will soon except PDF 1.7. Does this mean that you need to upgrade all of your PDF’s from 1.4 to 1.7?

There is a very simple answer – No.

The specifications for PDF are backward inclusive. This means that the PDF 1.7 specification includes all of the functionality previously documented in the Adobe PDF Specifications for versions 1.0 through 1.6. Below is a list of all of the new features that Adobe has implemented in the PDF specification. If you are not using any of the new features below, a PDF 1.7 file and PDF 1.1 file are identical, with the exception of the version number which is embedded in the metadata.

To find more information please click here: THE eCTD SUMMIT: Using Older PDF Versions

28 November 2011

CMDh: BEST PRACTICE GUIDE ON THE USE OF THE ELECTRONIC COMMON TECHNICAL DOCUMENT (ECTD) IN THE MUTUAL RECOGNITION AND DECENTRALISED PROCEDURES

The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) : Re-issue the Revision 3 of “BEST PRACTICE GUIDE ON THE USE OF THE ELECTRONIC COMMON TECHNICAL DOCUMENT (eCTD) IN THE MUTUAL RECOGNITION AND DECENTRALISED PROCEDURES” document.

To find the document please click the below web link

CMDh: BEST PRACTICE GUIDE ON THE USE OF THE ELECTRONIC COMMON TECHNICAL DOCUMENT (ECTD) IN THE MUTUAL RECOGNITION AND DECENTRALISED PROCEDURES

25 November 2011

AEMPS (Spain) eSubmission Guidance Updated - Minor changes

The Spanish Agency Medicines and Health Products (AEMPS) eSubmission Guidance got updated there is minor update in the Validator tool links.

To find the more information please click the following link

AEMPS (Spain) eSubmission Guidance Updated - Minor changes

24 November 2011

EMA: Sending electronic submissions (Human) via the eSubmission Gateway - Statement of Intent

The European Medicines Agency hereby announces plans to implement the eSubmission Gateway. The eSubmission Gateway will allow the electronic-only submission of all centralised procedure eCTD applications.

In this context, the European Medicines Agency is pleased to announce that a pilot phase for the eSubmission Gateway is starting on 9th of January 2012.

During the pilot phase the Gateway will be available to a limited number of applicants as a new submission channel through which all types of centralised procedure eCTD applications can be submitted to a limited number of applicants (e.g. new applications, supplementary information, variations and renewals).

The pilot phase will run for three months and the Agency would like to welcome all interested applicants to register for the pilot. To register, please follow the steps described in the Pilot Guidance document.

To find more information and download the document please click here: EMA: Sending electronic submissions (Human) via the eSubmission Gateway - Statement of Intent

Apex Regulatory's Blog: Fixing a broken MD5 checksum

Some eCTD publishing software comes with a tool which allows for the creation of xml files and valid MD5 checksums for eCTDs which have been published and then edited in the eCTD output folder. ISI’s eCTDXpress and eCTD Office are two publishing tools which incorporate this handy feature.

This feature is especially useful when making minor changes to the published eCTD, such as PDF file open settings, creating a new hyperlink or bookmark, etc., without the need to republish the entire eCTD in order to create the valid MD5 checksums.
Without such a tool, changes have to be made to source documents, usually within a document management system (DMS), and the entire eCTD will need to be republished.
Recently I’ve been using a publishing tool which does not include this handy function, and making these minor changes has been a needlessly annoying and time consuming task.
Fix MD5 is a useful (and importantly, free) tool for eCTD publishers who need to make small changes to an eCTD after it has been published.

To find more information please click here: Apex Regulatory's Blog: Fixing a broken MD5 checksum

23 November 2011

European Medicines Agency invites registrations for eSubmission Gateway

The European Medicines Agency is inviting pharmaceutical companies to register to take part in a three-month pilot of its eSubmission Gateway, beginning on 9 January 2012.

The eSubmission Gateway is a new electronic submission channel that applicants will be able to use to submit applications for centralised marketing authorisations for human medicines in the Electronic Common Technical Document (eCTD) format. This includes new applications, supplementary information, variations and renewals of marketing authorisation.

The Gateway will use a secure business-to-business transfer process to allow companies to send electronic applications to the Agency. This is expected to improve the speed and efficiency of the application process.

The pilot will be open to a limited number of applicants. Depending on its results, the Agency will consider extending use of the Gateway to all applicants.

The Agency is also working towards a web-based submission client for low-transmission volumes, which may be more suitable for small and medium-sized companies. It will announce plans for this client in the first quarter of 2012.

To find more information please click here: European Medicines Agency invites registrations for eSubmission Gateway

22 November 2011

Mission3: Submissions Management at a Glance - New Letter

Introduction

The globalization of clinical trials and introduction of new submission standards and regional requirements such as RPS, eCTD Version 4.0, SPL, CDISC, SDTM, etc. make planning and managing global submissions a huge challenge for Life Science companies. Authors now need to write “electronic documents” using predefined templates that help to link tables and figures and automate bookmarking while following regulations and guidance documents regarding content and format. Publishing no longer happens at the end of the submission process, but continuously throughout. There are many moving parts, components, and required resources that need to be managed; But by whom? Enter Regulatory Operations - the group who does “whatever it takes” to get a submission out on time.

Concept of Submission Management

It is often said that Regulatory Operations only has to “push a button” to create an electronic submission (just don’t say that to any of these mission critical people). While that may have been somewhat true in the past, it is not so today, where the global regulatory landscape has rapidly changed. The future is sure to bring even more changes and challenges.

Expectations of Regulatory Operations have been raised. The function within Regulatory Operations responsible for navigating the complex submission process, defining timelines and managing the publishing process is usually called Submission Management. Submission Managers provide centralized oversight and act as manager, facilitator, and troubleshooter across various functions. They are the “go to” person for submission team members and management because of their in-depth understanding of business requirements and industry standards in relation to supporting technologies and processes.

The Submission Management Process

The submission management process emphasizes upfront and ongoing management, well-defined roles and responsibilities, application of standards and technology, and continuous improvement. Submission Managers requires expertise in project and resource planning, vendor relations/contracts, publishing tools, process management and electronic submission strategy. Additionally, submission managers must be able to communicate and foster collaboration with all levels of the organization, especially management as well as CROs and Medical Writing, Quality and/or Preclinical consultants.

To find more information please click here: Mission3: Submissions Management at a Glance - New Letter

THE eCTD SUMMIT: FDA and PDF Specifications: An Evolving Matter - By Rahul Mistry

I am often asked, “Which version of Adobe Acrobat is the FDA using?”. This question is usually followed by, “Which version of PDF can I submit to the FDA?”.

The answer to the first question is that the FDA currently uses Adobe Acrobat 8 with plans of upgrading to the new version, Adobe Acrobat X, in the near future.

The answer to the second question is a bit more complicated. Since the FDA uses Adobe Acrobat 8, they have the ability to view PDF versions 1.0 to 1.7. That being said, they do not support all of these versions.

As many of you know, the FDA issues eCTD Guidance and Specifications to clarify implementation of regulations. In the currently posted specification concerning PDFs dated June 4, 2008, the official PDF version is 1.4, which is supported in Adobe Acrobat 5 and later.

To find more information please click here: THE eCTD SUMMIT: FDA and PDF Specifications: An Evolving Matter - By Rahul Mistry

03 November 2011

Integrated Regulatory Compliance Management: From Concept to Real World - How eCTD and DMS work together: Complimentary half day workshop in Munich

NextDocs and EXTEDO invite you to a half-day workshop covering the hot topics of eCTD / electronic submissions and document management.

By attending you will:

Hear about a successful project where a complete integration between eDMS and eCTD has been realized by Sanofi Pasteur MSD : Case Study
Learn how to work with eCTD
Understand why eCTD and Document Management System (DMS) belong together
Gain insight into Compliance without Complexity - 21CFR11 Compliant Document and Quality Management for Life Sciences

Experts from the leading service and solution providers will share their experience through presentations and live demos. See first-hand how easily documents and submissions can be managed using EXTEDO eCTDmanager integrated with the SharePoint-based Document Management System from NextDocs.

Speakers:

Nathalie Kalita, Head of Regulatory Operations and Compliance, Sanofi Pasteur MSD
Günter Rodenkirchen, Account Manager, EXTEDO GmbH
Prof. Dr. Thomas Städter, Managing Consultant, EXTEDO GmbH
Christophe Benninghoff, Pre-Sales Consultant, NextDocs Corporation
Romuald Brown, Business Manager, NextDocs Corporation

Session Agenda:

13:30 – 14:00 Registration
14:00 – 14:15 Opening Remarks and Introduction
14:15 – 15:15 Real example of a complete Information Management Process Integration for submission (Nathalie Kalita, Head of Regulatory Operations and Compliance, SPMSD)

Conception and design
Change Management and European Deployment
Lesson learned

15:15 – 15:30 Coffee Break
15:30 – 15:45 Compliance without Complexity - 21CFR11 Compliant Document and Quality Management for Life Sciences (Romuald Brown, NextDocs)

Company and Strategy Overview
Document & Quality Management System
Regulatory Submission, SOP, Clinical Trial
Interoperability & Integration

15:45 - 16:00 EXTEDO - Your partner for all electronic Regulatory Affairs issues (Günter Rodenkirchen, EXTEDO)

Overview about the product and service portfolio

16:00 - 17:00 Why eCTD and Document Management System (DMS) belong together (Prof. Dr. Thomas Städter, EXTEDO and Christophe Benninghoff, NextDocs)

Submission Management as a most complex ECM Process

DMS & eSubmission Requirements
Document- and Dossier Lifecycles
How NextDocs and EXTEDO eCTDmanager work together
Deployment Process

17:00 - 17:30 Q&A

Who Will Benefit?

Global project managers
Regulatory, medical, and technical writers
Biostatistics and data management Information technology
Clinical research & development/Clinical supplies
eClinical, Electronic regulatory submissions/Document management

Date & Venue:

Thursday, November 10th, 2011
13:30h - 17:30h

FOM University of Applied Sciences, Room A03
Arnulfstrasse 30 - about 100m from “Hauptbahnhof” / Main Station
80335 Munich

Email Thomas Kessler at kessler@extedo.com for more information

Registration:


The registration is free of charge, please register online with the form below until November 05.
Event date: 10/11/11 to
Location: Munich, Germany

To find more information please click here: Integrated Regulatory Compliance Management: From Concept to Real World - How eCTD and DMS work together: Complimentary half day workshop in Munich

FDA: Fiscal Year 2011 Innovative Drug Approvals and Drug Information - PDF Document For Download

FDA is approving innovative drugs earlier and faster than any other country in the world, while at the same time making sure that Americans’ medicines are safe and effective.

Over the last several years, FDA has improved the quality and speed of its drug approval process, making new treatments available for millions of Americans suffering from various serious health problems.

In Fiscal Year 2011 FDA approved 35 innovative drugs that offered important advances in treatment for hepatitis C, late-stage prostate cancer, lupus, drug resistant skin infections, pneumonia, and other serious and life-threatening diseases. This is among the highest number of approvals in the past decade, surpassed only by 2009 (37).

The report, FY 2011 Innovative Drug Approvals, provides details of how FDA used expedited approval authorities, flexible clinical trial requirements and resources collected under the Prescription Drug User Fee Act (PDUFA) to boost the number of innovative drug approvals.

To find more information and download the PDF document please click here: FDA: Fiscal Year 2011 Innovative Drug Approvals and Drug Information - PDF Document For Download

Life Science Leader: Scientific Articles: The Engine Inside Pharma

As a pharmaceutical company seeks to guide a new product from concept to commercial success, it must effectively harness an important tool: the scholarly research paper. A clear understanding of the roles an article can play and the challenges of maximizing its effectiveness are valuable knowledge for any pharma executive. Let’s first review the multiple roles a paper can play and then assess the challenges.

During the preclinical study phase, your company’s researchers will be navigating through the millions of articles that exist in support of the scientific process. After preclinical work, clinical trials are conducted and the publication-planning process accelerates, culminating in scholarly articles that will be submitted to peer-reviewed academic journals. Once published, they become a major part of your investigational new drug application (INDA) submitted to the FDA. If the FDA approves your product, the articles take on a new role as your marketing efforts begin. As witnessed by the growing importance of evidence-based promotions, there is no greater weapon in your sales representatives’ arsenal than research studies that can be effectively presented along with prescribing guidelines to the healthcare professionals (HCPs) with whom they meet. Being able to back up one’s claims for a medication with science — in addition to the promotional materials prepared by your marketing firm — is not only a good idea; it has become the chief method by which you can distinguish yourself from rival companies with competing drugs. It has also become one of the few ethical methods remaining to communicate with HCPs in light of the highly restricted code of interactions adopted within recent years.

To find more information please click here: Life Science Leader: Scientific Articles: The Engine Inside Pharma

02 November 2011

Ask CATO: Project Management for Biotech Companies

In today’s fast paced, high pressure world of drug development there are multiple factors that can and do affect marketing success. Large organizations understand the value that project management can contribute to a successful project. The smaller companies tend to lag behind and often do not recognize that project management is not too complex or does not cost too much to fit into their smaller culture. Project Management should not be considered as only a box of tools but a mindset on how to approach management of a project. A small company can get huge payback just by incorporating basic project management into their processes. Simple processes such as developing a project scope, identifying risks, and setting common goals for the project team performance can lead to benefits by shortening timelines, eliminating costly mistakes, and ensuring project success. A cooperative alliance between a biotech company and a contract research organization (CRO), such as Cato Research, can help bridge any gap that may exist in the company’s experience level and ensure clear communication among all the team members through experienced project management. Understanding the differences in the team’s work environments will lead to better communication and improve the overall performance.

Drug Development and Project Management: Who are the team members and what do they do?

Project teams are multidisciplinary and the ability of the CRO to fit into the company’s corporate culture and fill in the areas where additional expertise is needed are vital in drug development. In my experience, most biotechs stay “lean and mean” to avoid carrying excessive overhead costs which often means that not all disciplines are sufficiently covered inhouse. Disciplines involved in most drug delivery programs usually include R&D, CMC (synthesis/manufacture), nonclinical, clinical, CMC (final formulation), and regulatory. Each biotech is unique in the set of inhouse skills available, and by collaborating with the CRO, they can draw upon its multiple assets to fill in wherever additional help is needed for the particular drug and the regulatory pathway. There are complex team dynamics that exist in any multidisciplinary project team. Sources of conflict can develop due to the different work environments, the different priorities, or misunderstandings, and inadequate communication among the various team members. Additionally, environmental diversity among the various team members may arise from the different motives, the distinct rewards/recognition, and the unique regulatory constraints that each team member faces in their specific area.

To find more information please click here: Ask CATO: Project Management for Biotech Companies