ComplianceOnline

This in-person training program on the new Clinical Trials Regulation and regulatory affairs aspects of medicinal product development in the EU will discuss:

  • All regulatory aspects to ensure a smooth development, including how to obtain orphan medicinal product status from the EMA, as well as when to ask for scientific advice.
  • How to integrate paediatric studies in the development plan and information regarding the special regulatory aspects of advanced therapy medicinal products and oncology medicinal products.
  • The current system for clinical trials applications in the EU as well as the changes under the new Clinical Trials Regulation.
  • How to avoid the current situation where 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.
  • How the new regulation will change the way pharmaceutical companies handle the clinical trial approval process.
  • Timelines for companies to start preparing for these changes and implementations to allow optimal preparation.
Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
Attendance Certificate
$100 Gift Cert for next seminar

Learning Objectives:

Upon completion of this course, each participant will have a comprehensive knowledge and understanding of development regulatory affairs. Participants will have learned the following:

  • How to create a comprehensive regulatory plan
  • How to obtain orphan medicinal product status from the EMA
  • When to ask for scientific advice and how to do this
  • How and when to integrate paediatric studies in the development plan
  • What are the special regulatory aspects of advanced therapy medicinal products and oncology medicinal products
  • How the clinical trial approval process in the EU works and how this will change

Who will Benefit:

This course is specifically designed for:

  • Regulatory affairs officers and managers
  • Clinical trial associates
  • Clinical operations personnel
  • Personnel in the pharmaceutical and biotech industries who need a thorough understanding of the regulatory issues involved in the development of new medicinal products within the European Union
  • Individuals who are seeking to update their knowledge of recent regulatory changes and their impact on product development

Topic Background:

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. The new regulation will change the way pharmaceutical companies handle the clinical trial approval process, and companies need to start preparing for these changes and practices now. It is important to know the new procedures for approval of clinical trials to avoid delays and minimize the time for approval.

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Day 01(8:30 AM - 4:30 PM)
  • 08.30 AM - 09.00 AM: Registration
  • 09.00 AM: Session Start
  • Introductions and Agenda Review
    • Elements of development regulatory affairs
    • The regulatory plan
    • Overview of the EMA
  • Regulatory Strategy and Regulatory Plans (Including Target SmPC)
    • Structure of the regulatory plan
    • Sources for the regulatory plan
  • Pricing and Reimbursement
    • What is HTA?
    • HTA bodies
  • Scientific Advice
    • Topics for scientific advice
    • Briefing document
    • National versus EMA
  • Orphan Medicinal Products
    • What are orphan medicinal products?
    • Main incentives
    • Applying for orphan medicinal product designation
  • Paediatric Development
    • Paediatric investigation plans
    • Waivers/deferrals
    • PUMA
  • Advanced Therapy Medicinal Products
    • Definitions
    • Certification procedure
    • Guidelines
    • Practical exercise: Determine for various products if they fall under the ATMP definition
Day 02(8:30 AM - 4:30 PM)
  • Oncology
    • Why is development of oncology products different?
    • Preclinical considerations
    • The new clinical oncology guideline
  • SME Status
    • Advantages of SME status
    • How to apply for SME status
  • 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
  • How to Apply for a Clinical Trial Authorisation in the EU
    • The clinical trial directive
    • Outline of the procedure
    • Content of the IMPD and important guidance documents
  • Voluntary Harmonisation Procedure
    • Overview of the process
    • Advantages and disadvantages
  • Future Changes to the Clinical Trial Authorisation Process in the EU
    • The Clinical Trial Regulation
    • Impact on the pharmaceutical and biotech industry
  • Questions
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Adriaan Fruijtier

Adriaan Fruijtier
Regulatory Affairs Consultant

Adriaan Fruijtier graduated as a pharmacist from the University of Utrecht, Netherlands. Until March 2004, he headed 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 served as a project manager for oncology projects at the European Medicines Agency for four years in London.

He joined the European Medicines Agency from Novartis AG, Basel, Switzerland, where he was regulatory affairs project manager in the oncology group between 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.

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$1,699.00

Seminar One Registration (USD)

March 30-31, 2017, Zurich, Switzerland
(Registrations till January 15, 2017 - $1699)
(Registrations till February 20, 2017 - $1799)
(Registrations till March 5, 2017 - $1899)
(Registrations after March 5, 2017 - $1999)

$2,399.00

Seminar One Registration (USD) (With 2 Nights Stay)

March 30-31, 2017, Zurich, Switzerland

$7,799.00
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March 30-31, 2017, Zurich, Switzerland
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The registration fee includes: the workshop; all related course materials; morning tea/coffee, lunch and afternoon tea/coffee on both the days.


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Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).

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Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund — less a $200 administration fee. No cancellations will be accepted — nor refunds issued — within 10 calendar days before the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($200) will be transferred to any future ComplianceOnline event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.

In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

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After we receive the payment from the registered attendee, an electronic event pass will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the venue of the event.

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Location:

Zurich, Switzerland
(Venue to be announced shortly)

March 30-31, 2017

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  • Logo on promotional email campaign
  • Logo on name cards
  • A half page brochure advert
  • Exclusive stall at the entrance
  • A quarter page brochure advert
  • Moving banner ad on the website
Silver Partner
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  • Logo placement on the podium
  • Logo on the lanyards for all speakers
  • Exclusive stall at the entrance
  • A full page brochure advert
  • Moving banner ad on the website
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  • Logo on promotional email campaign
  • Logo on name cards
  • A half page brochure advert
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  • A quarter page brochure advert
  • Moving banner ad on the website

If you wish to sponsor this event please contact Cruise Webster: cwebster@complianceonline.com or call us: (207) 576-4173

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Local Attractions of Zurich, Switzerland

Kunsthaus Zurich

Kunsthaus Zurich

The Kunsthaus is Zurich's most important art museum and one of the most famous in Europe. Although the collection of the Kunsthaus Zürich ranges from Ancient times to the Victorian Era, the Swiss art museum is most noted for its modern and contemporary works from the 19th and 20th centuries. Top exhibits include the Giacometti wing and Rodin's Gate of Hell.

Bahnhofstrasse

Bahnhofstrasse

Widely known as the principal boulevard in Zürich, the Bahnhofstrasse is Zurich's most famous shopping street. Lined with some of the city's most elegant boutiques and top department stores, the Bahnhofstrasse offers a delightful place for a day of shopping amongst some of the world's greatest luxury brands and jewelry stores.

Zurich Zoo

Zurich Zoo

Elephants, rhinos, tigers, penguins and 20 species of monkeys are just some of the more than 360 animal species that can be admired at the Zurich Zoo. In the Masoala Rainforest Hall visitors can experience a piece of Madagascar first hand. A must-see for young and old.

Limmat River

Limmat River

Switzerland's Limmat River is actually part of the Linth river, which continues from Lake Zurich. Zurich is the most famous city located along the Limmat Valley and the Limmat River provides a charming and beautiful waterway to explore the sights of Zurich by boat.

Fraumunster Church

Fraumunster Church

The Fraumünster Church overlooks one of Zurich's oldest squares and markets, the Münsterhof. Tracing its founding back to 853, when it was a Benedictine abbey, the church is home to five famous stained-glass windows by renowned artist Marc Chagall.

Zurich Old Town

Zurich Old Town

Zurich Old Town (Altstadt ) is a cultural, social and historical melting pot. The highest concentration of clubs in Switzerland, one of the most famous shopping miles, and a plethora of cultural offerings

Schweizerisches Landesmuseum

Schweizerisches Landesmuseum

The Schweizerisches Landesmuseum (or Swiss National Museum in English) occupies an imposing neo-Gothic building, which houses a huge collection of objects documenting the Swiss peoples and their history. The collections range in date from prehistoric to modern times.

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