Thu, Jun 15, 2017, 02:30 PM - Fri, Jun 16, 2017, 11:30 PM
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:
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.
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:
Who Will Benefit:
Day 1 Schedule
Regulatory strategy and regulatory plans (including target SmPC)
Pricing and reimbursement
Orphan medicinal products
Day 2 Schedule
Advanced Therapy Medicinal Products (ATMP)
Practical session: regulatory plan
How to apply for a clinical trial authorisation in the EU
Voluntary Harmonisation Procedure (VHP)
Overview of the process
Future changes to the clinical trial authorisation process in the EU
Interactive discussion: what are the advantages and disadvantages of the new Regulation?
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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Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900936SEMINAR?channel=mailer&camp=Seminar&AdGroup=_June_2017_SEO
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