Overview:
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 strategy
· Pricing and reimbursement issues in your development
· Orphan medicinal Products
· Scientific advice and how to choose between centralised and national scientific advice
· Paediatric Investigation Plans
· Advanced Therapy Medicinal Products
· Oncology medicinal products
Who will benefit:
· Executives of Dietary Supplement companies
· Regulatory Compliance Professionals
· Quality Assurance Professionals
· Dietary Supplement Manufacturers
· Dietary Supplement Distributors
· Directors
· Managers
· Supervisors
· Quality Control
Day One:
Lecture 1: Introduction
· 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 is scientific advice needed and useful, at what point in the development seek for SA
· Topics for scientific advice
· Briefing document, timelines and planning: from submission to final SA 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 status
Day Two:
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: Oncology
· 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 product
· Does it qualify for orphan drug designation?
· How to propose the optimal orphan indication
· Paediatric studies necessary?
· Scientific advice: Topics, selection of authorities
Lecture 4: How to apply for a clinical trial authorisation in the EU
· The clinical trial directive
· 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: Overview of the process
· Advantages and disadvantages
Lecture 6: Future changes to the clinical trial authorisation process in the EU
· The Clinical Trial Regulation
· Impact on the pharmaceutical and biotech Industry
Lecture 7: Interactive discussion: what are the advantages and disadvantages of the new Regulation?
Adriaan FruijtierAdriaan 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.
Location: Zurich, Switzerland Date: May 21st and 22nd, 2015 Time: 9:00 AM to 6:00 PM
Venue: WILL BE ANNOUNCED SOON
Price: $1,595.00 (Seminar for One Delegate)
Register now and save $200. (Early Bird)
Until April 20, Early Bird Price: $1,595.00
From April 21 to May 19, Regular Price: $1,795.00
Contact Information:
NetZealous LLC,
DBA GlobalCompliancePanel
161 Mission Falls Lane,
Suite 216, Fremont, CA 94539, USA
USA Phone: 800-447-9407
Fax: 302-288-6884
support@globalcompliancepanel.com
http://www.globalcompliancepanel.com
Event Registration Link - http://bit.ly/1O9u8zf
Overview: This seminar is mainly based on the IEC62304:2006 standard and will...
Q
Overview: This course will present, in one place, the regulations and...
Q
Overview: We will be discussing the history and evolution of HIPAA...
Q
Overview: This two day seminar will provide the foundation for the...
Q
Overview: Most specialists strongly recommend to sample every meter of the...
Q
Overview: QMS is the catch phrase for accreditation and is the backbone of...
Q
Overview: This hands-on course will provide attendees with an understanding of...
Q
Overview: Upon completing this course participants should: · ...
Q
Overview: Prior to developing a process control plan as part of an overall...
Q
Overview: Topics included will include the filing of New Drug Submissions for...
Q
Overview: This course provides a basic overview of the laws and regulations...
Q
Overview: Why companies are prone to having past problems in new devices? One...
Q
Overview: The 2-day seminar begins with an examination of ISO and FDA...
Q
Overview: Prior to developing a process control plan as part of an overall...
Q
Overview: This program is designed to provide participants...
Q
Overview: FDA's and the Customs and Border Patrol Service (CBP) have become...
Q
Overview Throughout 21 CFR and guidance documents for the pharmaceutical,...
Q
Overview: We will be discussing the history and evolution of HIPAA...
Q
Overview: The FDA's Quality System Regulation (QSR) requires device...
Q
Overview: This 2-day seminar provides a 1-day introduction to the statistical...
Q
Overview: With all of the deadlines, projects, and tasks that you have to do...
Q
Overview: Real world examples of what to expect, and what to prepare for...
Q
Overview: This course provides a basic overview of the laws and regulations...
Q
Overview: Upon completing this course participants should: · ...
Q
Overview: The FDA recalls related to software performance are on the increase...
Q
Overview: QMS is the catch phrase for accreditation and is the backbone of...
Q
Overview: Prepare yourself to take on the role of the Corporate Controller....
Q
Login to comment