ECTDSUBMISSIONS

2-Day Course

COURSE OVERVIEW

The process of collating, developing, submitting, and managing a

regulatory submission for approval is a complex project where

masses of data must be collated and speed is critical. The electronic

CTD (eCTD) has simplified the submission process speeding up your

data through the approval process, saving you valuable resources and

time. Although much simpler, the eCTD still handles large documents

and must be led by professionals who are knowledgeable and

competent to minimise delays.

Global regulatory agencies are committed to implementing the eCTD

as standard so regulatory professionals must stay up-to-date with the

latest regulations and trends. On completion of this 2-day course, you

will understand how to organise applications in the correct electronic

format and style ready for submission. You will also examine life cycle

eCTD management to ensure you are capable of managing the

submission post-approval.

Discover practical

solutions for managing

global regulatory

requirements and new

challenges

Having finished his degree in Chemistry at Heidelberg University, Germany,Karl-Heinz Loebel joined a Biotech start-up company as Scientific Advisor andManagement Executive for several years. In early 2005 he joined PharmaLexInternational and was recently promoted to Head of Regulatory Operations.

MEET THE TRAINERS

KARL HEIN-LOEBEL

SILKE NOLKEMPERSilke Nolkemper studied pharmacy and holds a PhD in PharmaceuticalBiology from the University of Heidelberg, Germany. She has more than 7years’ experience as Regulatory Affairs Manager in the pharmaceuticalindustry, spending time at PharmaLex, Sandoz/HEXAL and finally Extedowhere she is responsible for the implementation of regulatory updatesregarding eSubmission (eCTD, NeeS, eCopy, VNeeS, ASMF, DMF).

Introduction – from CTD to eCTD, electronically from applicant to agencyTracking the progress and success of the eCTD around the globe

Examining the eCTD validation and review processAssessing the impact on eCTD submission review for both agency and applicant?What are the challenges of using the eCTD?

Organising your eCTD – Options for structure and designReusability of eCTDs across regionsOvercoming Module 1 issues

Clarifying the impact of the eCTD on the regulatory submission process (part 1)

Clarifying the impact of the eCTD on the regulatory submission process (part 2)

Clarifying the impact of the eCTD on the regulatory submission process (part 3)

DAY ONE

Transforming documents into an electronic dossierCreating PDFs from word documentsExamining the use of hyperlinks – when, where and how manyDiscussing common pitfalls and how to avoid them

How to move from paper to eCTD?

Preparing for your e-submissions (part 1)

Preparing for your e-submissions (part 2)

Summary and Q&A

DAY ONE

Overview of electronic submission in EuropeEvaluating the challenges towards technical harmonisationEuropean Heads of Medicines Agencies’ eSubmission roadmapOnline submissions – through gateways and portals

Harmonised procedures in the EU

DAY TWO

Effective eCTD lifecycle managementeCTD lifecycle operatorseCTD lifecycle challenges and managementValidation

Tracking and reporting on how previously submitted documents are affected byvariations and amendments.Maintaining control of an evolving dossierEnsuring you capture all lifecycle documents, including responses to questions,variations/amendments, and RenewalsManaging document obsolescence efficientlyManaging an eCTD lifecycle through single or multiple agencies

Practical exercise: Lifecycle management

DAY TWO

Creating file/folder structure and assigning documentsHyperlinks and eCTD attributesBuilding the required XML backbone and regional XML

Time management and project planning for eSubmissions

eSubmission Strategy & eSubmission project management

Building and submitting an eCTDeCTD creation and assembly

Regulatory requirements for product lifecycle

Practical exercise

DAY TWO

What is XML and where is it used in the eCTD?Understanding the general concepts, terms and “Util” directoryExamining the role of XML in the future

CTD in depth - XML

Discussion and Q&A

DAY TWO

Dossier ManagementDocument ManagementData ManagementComplianceElectronic Publishing/ SubmissionsGlobal Project ManagementIT/ISEDMS

This course is targeted towards regulatory affairsprofessionals working in submissions procedures.

WHO IS THISCOURSEFOR?

For information contact our training consultants

Jessica PurnellJessica.Purnell@informa.com

+44 (0)20 7551 9521

Group bookingsReceive 10% off for 3-4 bookingsReceive 15% off for 5+ bookings