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The New Clinical Trials Regulation and Regulatory Affairs Aspects 2017

Thursday, Jun 15, 2017 at 9:00AM - Friday, Jun 16, 2017 at 6:00PM

Zurich, Switzerland

  • Jun 2017

    15 Thu


  • Jun 2017

    16 Fri


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The New Clinical Trials Regulation and Regulatory Affairs Aspects 2017

Thursday, Jun 15, 2017 at 9:00AM - Friday, Jun 16, 2017 at 6:00PM

Zurich, Switzerland, SC

No tickets available


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

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
  • Pricing and
    reimbursement issues in your development
  • Orphan medicinal
  • Scientific advice and
    how to choose between centralised and national scientific advice
  • Paediatric Investigation
  • Advanced Therapy
    Medicinal Products
  • Oncology medicinal

Who Will

  • Regulatory Affairs
    personnel involved in Development of medicinal products


Day 1 Schedule

Lecture 1:


  • Elements of development
    regulatory affairs
  • The regulatory plan
  • Overview of the European
    Medicines Agency

Lecture 2:

Regulatory strategy and regulatory plans (including
target SmPC)

  • Structure of the
    regulatory plan
  • Sources for the
    regulatory plan

Lecture 3:

Pricing and reimbursement

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

Lecture 4:

Orphan medicinal products

  • Rare diseases: orphan
    medicinal products?
  • Main incentives
  • Applying for orphan
    medicinal product designation

Lecture 5:

Scientific advice

  • Why and when is
    scientific advice needed and useful?
  • Topics for scientific
  • Briefing document,
    timelines and planning: from submission to final scientific advice by CHMP
  • National versus EMA
  • Joint scientific advice
    CHMP + HTA bodies: benefits and issues to consider

Lecture 6:

Paediatric development

  • Research and development
    programme for medicines in children: Paediatric Investigation Plans
  • Cases in which studies
    in children are not needed or will be done later: Waivers/deferrals
  • What is a paediatric use
    marketing authorisation (PUMA)?

Lecture 7:

SME status

  • Advantages of micro-,
    small- and medium-sized-enterprise (SME) status
  • How to apply for SME

Day 2 Schedule

Lecture 1:

Advanced Therapy Medicinal Products (ATMP)

  • Definitions
  • Early scientific
    evaluation of quality and non-clinical data: Certification procedure
  • Guidelines
  • Practical exercise:
    Determine for various products if they fall under the ATMP definition

Lecture 2:


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

Lecture 3:

Practical session: regulatory plan

  • Case study: New oncology
  • Does it qualify for
    orphan drug designation?
  • How to propose the
    optimal orphan indication
  • Paediatric studies
  • Scientific advice:
    Topics, selection of authorities

Lecture 4:

How to apply for a clinical trial authorisation in the

  • The clinical trial
  • Outline of the procedure
  • Content of the
    Investigational Medicinal Product Dossier and important guidance documents

Lecture 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

Lecture 7:

Future changes to the clinical trial authorisation
process in the EU

  • The Clinical Trial
  • Impact on the
    pharmaceutical and biotech Industry

Lecture 8:

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


Adriaan Fruijtier

Regulatory Affairs Consultant, CATS Consultants

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




$1,695.00 (Seminar Fee for One Delegate)


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


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


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