Electronic submissions

are a challenge to master in the area of crop protection and other regulated domains: How  can data and documents to be submitted be best indexed, organized and lifecycled? How can dossiers be prepared and managed over time?  How to best manage document-centric (e.g. PDF-based) and data-centric submissions (like IUCLID) in parallel? What formats can be used to transport the information to authorities? What products, tools and techniques are there?
I have  profound expertise to assist you with those types of questions

My profile

My name is Georg Schifferdecker. I am located close to Frankfurt, Germany.

I joined Hewlett-Packard in 1997. Within HP I  have been working as senior consultant and solution architect in the area of document management, archiving for more than 20 years, working for customers in public, industry, transportation. Since 2005 I started specializing in the domain of regulatory affairs, especially focused around the creation, management and electronic submission of dossiers from industry to authority.  I have left HP on September 30th, 2017 and since then work as an independent consultant. 

I am currently working for multiple global players in the crop protection domain, helping the companies to rethink and reimplement the system landscape used for electronic submissions, consisting of systems for document management, dossier creation, dossier publication, as well as surrounding systems like reference data systems or planning systems. I am also working for the European industry association for crop protection and am responsible for the organization of industry meetings as well as for the maintenance of electronic submission standards. I have been engaged by a European authority to assists with the processing of an electronic submission standard. In the part years I have been working intensively with IUCLID as the new tool for substance registrations in Europe. I am the solution architect for different tools supporting the efficient data transfer into IUCLID. 

I have certifications for solution architecture (HP ITSA, TOGAF), ITSM (ITIL v3 foundation) and various soft skills and project management trainings. I speak German, English and French fluently.

Services

Business Consulting

I offer business consulting for all questions related to the electronic submission process in crop protection and other regulated domains.

Requirements management

I am specialized in the requirements management using all kinds of techniques, in order to get a proven set of requirements for subsequent implementation phases.

Solution Architecture

I have extensive experience from various project to develop a functional solution architecture for a dedicated system or application landscape.

Facilitation

I like to work and communicate with people in order to get sustainable results. Preparing and moderation of workshops is a key component for success in getting good team results.

Tools and standards

IUCLID

Experienced in IUCLID and surrounding tools in different client contexts.

Digital transformation

Of course a high-level buzzword, but can deliver business value for regulatory document and dossier management when combined with a solid understanding of the underlying processes, techniques and key design principles.

GHSTS and CADDY

Support and maintenance for the submission standards on European and OECD level.

Veeva

Solid understanding of Veeva for regulatory document and dossier management

References

Support of the eSEG expert group from CropLife Europe . Maintenance of the European electronic eSubmission CADDY standard and surronding tools. 

Participant in the EFSA Hypercare phase for the introduction of IUCLID as industry consultant. Execution of various technical assessments of IUCLID for industry. Solutioning solutions to overcome IUCLID limitations in terms of functionality and efficiency.                                              

Member of the EGEEPD working group for electronic submissions on OECD level, with significant contributions to the development of the GHSTS submission standard.
Long-term support in analysis and redesign of the application landscape for dossier submission for a global player in agrochemical submissions. 

Solution architect for a mass archive for a global logistics provider, now archiving around 10 million documents a year. Transitioning of the service to a private cloud environment.

Solution architect and designer for a web-based scanning solutions for a German authority, replacing fat-client scan applications. Price winner in 2017 German e-government competition.

Contact

I am interested in projects in Germany or worldwide, from short-term consulting engagements to long-term architecture engagements. If you want to know more about my skills and are interested in my services, please contact me via the email in the Impressum and I will get back to you as soon as possible.