The New Clinical Trials Regulation and Regulatory Affairs Aspects 2017

The New Clinical Trials Regulation and Regulatory Affairs Aspects 2017

NetZealous DBA as GlobalCompliancePanel 15/06/2017 to 16/06/2017 | USA, Hilton Zurich Airport Hohenbuhlstrasse 10, 8152 Opfikon-Glattbrugg, Switzerland. +41 44 828 50 50

Course "The New Clinical Trials Regulation and Regulatory Affairs Aspects of Medicinal Product Development in the EU" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.


The main document from a regulatory perspective in the development of a medicinal product is the regulatory plan. In this Seminar it is explained how to write the regulatory plan, and which aspects to consider.

The regulatory plan describes the regulatory strategy, as well as pricing and reimbursement issues in your development. Orphan medicinal Products will be discussed, and the advantages of having a status as an orphan medicinal product will be explained.

Scientific advice is a vital element in the development of a medicinal product, and knowledge of the how to choose between national and EU scientific advice, as well as the preparation and procedure is vital for a successful outcome

Paediatric Investigation Plans are becoming increasingly important, and failure to integrate paediatric studies in the development may lead to a delay in approval.

Many of the products currently in development are Advanced Therapy Medicinal Products and medicinal products used in oncology, and special considerations for the products must be considered.

An overview of the current process for clinical trial applications is included, but the Seminar will also look ahead and describe the effects of the Clinical Trials Regulation.

The Clinical Trials Regulation aims to create an environment that is favourable for conducting clinical trials, with the highest standards of patient safety, for all EU Member States. Intrinsic to this is the simplification of current rules, for example:

A streamlined application procedure via a single entry point - an EU portal and database, for all clinical trials conducted in Europe. Registration via the portal will be a prerequisite for the assessment of any application;A single authorisation procedure for all clinical trials, allowing a faster and thorough assessment of an application by all Member States concerned, and ensuring one single assessment outcome and authorisation per Member State;The extension of the tacit agreement principle to the whole authorisation process which will give sponsors and researchers, in particular SMEs and academics, more legal certainty;Strengthened transparency for clinical trials data.Ethics committees will be involved in the assessment of clinical trials application. However, as with the current situation, their responsibilities and detailed composition will be determined independently by each EU country. In this way the different traditions in the various Member States are respected.

The Regulation, while continuing to uphold patient safety, takes better account of the actual risk to which subjects will be exposed during the clinical trial and adapts the regulatory burden in relation to the risk posed. It introduces the concept of a 'low-intervention clinical trial' - an example being clinical trials comparing already authorised medicines. In such cases, the regulatory requirements will be lighter. Transparency on the conduct and results of clinical trials has several benefits, and the Regulation strengthens the rules accordingly. Transparency avoids redundancy and duplication. It ensures that even clinical trials with unfavourable results are made public, thereby avoiding 'publication bias'. Finally, transparency gives patients the possibility to find out about on-going clinical trials in which they may wish to participate.

Why should you attend:This seminar is specifically designed for personnel in the pharmaceutical and biotech industries who need to understand the regulatory issues involved in applications for clinical trial approval and clinical development of new medicinal products within the European Union.

Upon completion of the program, participants will be able to create a comprehensive regulatory plan. All regulatory aspects to ensure a smooth development will be discussed, including how to obtain orphan medicinal product status from the EMA, as well as when to ask for scientific advice.

Additionally, the topic of how to integrate paediatric studies in the development plan will be discussed along with information regarding the special regulatory aspects of Advanced Therapy Medicinal Products and Oncology Medicinal Products.

It is important to know the new procedures for approval of clinical trials to avoid delays and minimize the time for approval. The current system for clinical trials applications in the EU will be reviewed, as well as the changes under the new Clinical Trial Regulation.

In the current situation, a common protocol is proposed in all EU Member States that participate in a clinical trial but requests for amendments may result in country-specific changes that require subsequent amendments in other countries to maintain a common protocol. In the Seminar it will be explained how this problem can be avoided.

The new Regulation will change the way pharmaceutical companies handle the clinical trial approval process, and companies need to start preparing for these changes now. The timelines for implementation will be discussed in this Seminar to allow optimal preparation.

Areas Covered in the Session:

Developing a regulatory strategyPricing and reimbursement issues in your developmentOrphan medicinal ProductsScientific advice and how to choose between centralised and national scientific advicePaediatric Investigation PlansAdvanced Therapy Medicinal ProductsOncology medicinal productsWho Will Benefit:

Regulatory Affairs personnel involved in Development of medicinal productsAgenda:

Day 1 Schedule

Lecture 1:


Elements of development regulatory affairsThe regulatory planOverview of the European Medicines AgencyLecture 2:

Regulatory strategy and regulatory plans (including target SmPC)

Structure of the regulatory planSources for the regulatory planLecture 3:

Pricing and reimbursement

What is Health Technology Assessment (HTA)?Who decides on pricing and reimbursement: the HTA bodiesLecture 4:

Orphan medicinal products

Rare diseases: orphan medicinal products?Main incentivesApplying for orphan medicinal product designationLecture 5:

Scientific advice

Why and when is scientific advice needed and useful?Topics for scientific adviceBriefing document, timelines and planning: from submission to final scientific advice by CHMPNational versus EMAJoint scientific advice CHMP + HTA bodies: benefits and issues to considerLecture 6:

Paediatric development

Research and development programme for medicines in children: Paediatric Investigation PlansCases in which studies in children are not needed or will be done later: Waivers/deferralsWhat is a paediatric use marketing authorisation (PUMA)?Lecture 7:

SME status

Advantages of micro-, small- and medium-sized-enterprise (SME) statusHow to apply for SME statusDay 2 Schedule

Lecture 1:

Advanced Therapy Medicinal Products (ATMP)

DefinitionsEarly scientific evaluation of quality and non-clinical data: Certification procedureGuidelinesPractical exercise: Determine for various products if they fall under the ATMP definitionLecture 2:


Why is development of oncology products different?Preclinical considerations: Which animal studies are needed for oncology products?The new clinical oncology guidelineLecture 3:

Practical session: regulatory plan

Case study: New oncology productDoes it qualify for orphan drug designation?How to propose the optimal orphan indicationPaediatric studies necessary?Scientific advice: Topics, selection of authoritiesLecture 4:

How to apply for a clinical trial authorisation in the EU

The clinical trial directiveOutline of the procedureContent of the Investigational Medicinal Product Dossier and important guidance documentsLecture 5:

Voluntary Harmonisation Procedure (VHP)

Harmonisation of assessment of clinical trial applications in several EU countries through the VHP:Lecture 6:

Overview of the process

Advantages and disadvantagesLecture 7:

Future changes to the clinical trial authorisation process in the EU

The Clinical Trial RegulationImpact on the pharmaceutical and biotech IndustryLecture 8:

Interactive discussion: what are the advantages and disadvantages of the new Regulation?


Adriaan Fruijtier, Regulatory Affairs Consultant, CATS Consultants GmbH 

Adriaan Fruijtier has graduated as a pharmacist at the University of Utrecht, The Netherlands.

He is currently Director Regulatory Affairs at CATS Consultants. Until March 2004 he has been Head of the Oncology Group within Global Regulatory Affairs at Bayer AG, Wuppertal, Germany, and Bayer Corporation, West Haven, CT, USA. Between 2001 and 2003 he was Director of Regulatory Affairs at Micromet AG, a biotech company in Munich, Germany. Prior to joining Micromet he has worked during four years as a Project Manager for Oncology Projects at the European Medicines Agency in London, United Kingdom.

He joined the European Medicines Agency from Novartis AG, Basel, Switzerland, where he was Regulatory Affairs Project Manager in the Oncology group in 1996 and 1997.

Before 1996 he was Head of Drug Regulatory Affairs for six years at Ciba-Geigy in the Netherlands, and has worked as Manager Regulatory Affairs at Glaxo, also in the Netherlands.

Location: Zurich, Switzerland Date: June 15th & 16th, 2017and Time: 9:00 AM to 6:00 PM

Venue: Hilton Zurich Airport

Address: Hohenbuhlstrasse 10, 8152 Opfikon-Glattbrugg, Switzerland. +41 44 828 50 50


Price: $1,695.00 (Seminar Fee for One Delegate)

Register for 5 attendees Price: $5085.00 $8,475.00 You Save: $3390.00 (40%)*

Until May 10, Early Bird Price: $1,695.00 from May 11 to June 13, Regular Price: $1,895.00

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NetZealous DBA as GlobalCompliancePanel

Phone: 1-800-447-9407

Fax: 302-288-6884



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