Course Description:

This interactive two day seminar will cover the various licensing methods (for Drugs, Biologics & Combination Products) by which applicants can file for product licenses (Marketing Authorizations) in one or multiple Member States, as well as fully across all Member States of the European Union. This course specifically outlines and discusses the structure of the regulatory agencies at the EU-level and across specific Member States. Course content will explain which procedures are available for which products and then will follow the license processing steps for each pathway.

This two day interactive course on European Clinical Trial Directive will cover:

  • Requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Directive (for Drugs, Biologics & Combination Products);
  • Recent updates on EU-GCP associated with the Directive;
  • Highlights of the new EU Pharmacovigilance Directive, as it relates to studies and helpful tips into working with the European regulators;
  • Changes to the Clinical Trial Directive that are being contemplated and may receive modification.


Learning Objectives:

Attendees will leave the Course clearly understanding the requirements under the current Directive. This course is designed to provide an overview of the regulatory environment throughout Europe and will provide training in:

  • How the EU and individual countries within Europe interact
  • Which registration procedure to use
  • How regulations effect product development strategies
  • Pricing issues – Coordinated filing vs. Individual filing
  • Understanding the concerns/issues of European Regulatory Personnel
  • How to negotiate with the regulators
  • Information necessary for effective submissions
  • Strategies for streamlining the registration application process for faster approval
  • The advantages and disadvantages of various registration procedures
  • How to efficiently initiate trials…..first patient, first visit
  • How to link the strategy of Country Selection to an ultimate EU Licensing Plan
  • Efficiently implementing studies via project teams and CROs at the National and multi-state level
  • How to stay compliant…..What can make the difference in your data passing Regulatory scrutiny
  • Related area-GCP and PV-reporting updates
  • EUCTD vs. FDA Regulations


Areas Covered in the Seminar:

  • Overview of the EU and EU Regulatory Structure
  • Overview of the EU Clinical Trial Directive and the 2007 Pediatric legislation
  • Marketing Authorization Options in the EU
    • Mutual Procedure
    • Decentralized Procedure
    • Centralized Procedure
  • Common Technical Document
  • Clinical Trials in the EU
    • Phases of a clinical trial
    • Start Up and Application Processes
    • Ethics Committee and Competent Authority Review Process
    • Trial Protocol and Management
    • GCP and GMP Compliance
    • Fees
  • End of a Clinical Trial
  • Variations, Renewals and Changes to Marketing Authorizations and Clinical Trial Applications
  • Generics, Orphan Drugs, Biologics and Combination Products
  • Overview of the New Pharmacovigilance Directive and Regulations
  • European Union vs. The United States
  • Navigating the Regulatory Process
  • How the EUCTD Affected CROs
  • Update to the Directive
  • Current Events
  • Appendix
    • EU Healthcare Authorities
    • Abbreviations Glossary


Who will Benefit:

  • Clinical Operations Staff
  • Project Team Members
  • Quality Assurance, Monitors, CRAs
  • Regulatory Affairs Personnel
  • Investigators & Site Study Staff
  • Clinical Trial Supply
  • CROs, Consultants, Insurers




Course Outline:

Day One (8:30 AM - 4:30 PM) Day Two (8:30 AM - 4:30 PM)

Registration Process: 8:30 AM - 9:00 AM

Session Start Time: 9:00 AM

Overview of the European Union

Regulatory Overview of the EU

  • Government Agencies
  • European Medicines Agency
    • Scientific Committees
    • Working Groups

The EU Clinical Trial Directive

  • Development of the EUCTD
  • What is in the EUCTD
  • Goals of the EUCTD
  • 2007 Paediatric Legislation
    • Objective of the Paediatric Legislation
    • Paediatric Committee
    • Paediatric Investigation Plan (PIP)

Marketing Authorization Options in the EU

  • Mutual Recognition
  • Decentralized Recognition Procedure
  • Centralized Procedure

Common Technical Document

  • What is it?
  • Overview of the CTD structure
  • eCTD

Clinical Trials in the EU

  • Phases of a clinical trial
  • Trial Startup and Application Process
  • The Ethics Committee
  • The Competent Authority
  • Trial Protocol and Management
  • Investigational Medicinal Product Dossier
  • Good Clinical Practice
    • Commission Directive
    • GCP Guidelines
    • GCP Inspections
  • Good Manufacturing Practice
    • Commission Directive
    • GMP Guidelines
    • GMP Inspections
  • End of a Clinical Trial

    Pharmacovigilance
    • What is it?
    • The new Pharmacovigilance Regulations and Directives
      • GVP Modules
      • How legislation will improve patient safety
      • Legislation’s affect of Marketing Authorization Holders
      • Adverse Reaction Reporting
      • Labeling Changes
      • Pharmacovigilance Risk Assessment Committee
    • Guidelines on GVP Modules
      • GVP Modules I-XVI
    • Generics
    • Orphan Drugs
    • Biologics
    • Combination Products
    • Variations
    • Stability Studies
    • Advertising
    • Fees
    • Marketing Authorization Holders Responsibilities
      • Maintaining your license
      • Renewals
    • US vs EU
      • Differences within the EU Member States
        • Sweden
        • Finland
        • UK
      • United States
    • Navigating the Regulatory Process
    • How the Directive affected CROs
    • Updates to the Directive
    • Current Events in the EU





Meet Your Instructor

Robert J. Russell
President of RJR Consulting, Inc

Robert J. Russell, (Bob) is the President of RJR Consulting, Inc., a Global Regulatory Consulting company, specializing in understanding regulatory issues for the pharmaceutical, medical device and combination products industry. Bob has more than 30 years of experience working with FDA, EMA, Healthcare Authorities and Agencies across Latin America, Middle East and Asia / Pacific supporting clients projects in these regions. Licensing, registrations, GMP, DMFs and borderline products are core competencies of the Course Director.

Prior to entering the consulting field, Mr. Russell was the Global Director of Regulatory Affairs for two Fortune 100 manufacturers of Drugs and Medical Devices. RJR's offices are located in every major region with in-country experts on staff handling local regulatory needs. Bob has a BS and MS in Chemistry.





Register Now

Online using Credit card


Get the Invitation
Pre-Register yourself and get the official Invite when venue and dates are announced for this seminar.
Call here to register +1-888-717-2436 or email at [email protected]

Other Registration Option

By order form / PO#

Payment Mode

By Check -
Pay your check to (payee name) “MetricStream Inc” our parent company and Mail the check to:

ComplianceOnline (MetricStream, Inc),
6201 America Center Drive Suite 240
San Jose, CA 95002
USA

By Wire -

Register / Pay by Wire Transfer

Please contact us at +1-888-717-2436 to get details of wire transfer option.

Terms & Conditions to Register for the Seminar/Conference/Event

Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ [email protected]

Payment:
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).

Cancellations and substitutions:
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.

Attendance confirmation and documents to carry to the seminar venue:
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.

Conference photograph / video:
By registering and attending ComplianceOnline conference, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to ComplianceOnline using these photos and videos for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline from any kind of claims arising out of copyright or privacy violations.

Media Partners

Sponsors



Media Partner Benefits
  • Logo and company data on the event website.
  • Logo on the conference material distributed during the conference.
  • Media partner’s brochure distributed along with conference material.
  • Logo on all the mailings before and after the event.
  • 10% discount to media partner's subscribers.


Media Partner To Do
  • Banner (min 728x90 or 468x60) on the media partner website.
  • Insertion of the event in the event calendar, both printed and/or online.
  • Announcement article of the conference on the magazine and/or website.
  • Dedicated email blast to media partner’s subscribers.
  • Article on the magazine and/or website after the conference.






Local Attraction

More than 450 activities await you at this non-profit facility dedicated to promoting a better understanding of science and technology. The Saunders Planetarium shows you the stars. Step inside the Gulf Coast Hurricane exhibit for a blast of tropical nightmare. At the IMAX Dome Theatre, the world is bigger than life, filled with odd sights and sounds on a huge screen. Souvenirs ranging from totes and T-shirts to puzzles and posters are available at the Science Store. For refreshment, the MOSI Café offers pizzas, salads and sandwiches. In late February, the BARF (Bay Area Renaissance Festival) takes place here.




Housing the largest collection of Salvador Dali works in the world, the museum offers a regularly changing exhibit of the legendary surrealist artist's melting-watch canvases and a wide variety of his sculpture and fiber objects that are, at the very least, intriguing. One memorable creation toasts the cocktail party; it is a vest covered with full glasses of creme de menthe. Daily tours seek to explain this complex man and his equally complex art. In the museum store you can select a memento of your surreal experience. Do check the website or call for timings.




Established in 1979, this museum houses more than 4,500 objects in its permanent collection and exhibits the largest collection of Greek and Roman antiquities in the Southeast. The Center Gallery displays themed exhibitions from the permanent collection. For a look at 19th and 20th century sculpture set against the backdrop of the Hillsborough River, visit the Terrace Gallery. Stroll through the Outdoor Courtyard featuring contemporary sculptures, fountains and bronze work. For gifts, books, children's items or home accessories, stop by the museum store.




Craftsman House is a gallery that showcases contemporary art works. The lush green lawns and beautiful garden welcome visitors in to this creative space. Owned and managed by Stephanie Schorr, it is a gallery-cum-working studio. Here, you will see umpteen art works displayed; jewelry, glass designs and much more work of local and national artists make for its splendid collection. It also has an on-site café serving delicious short eats and variety of beverages including beer and wines. Apart from the art works, Craftsman House also has a pottery studio that features colorful mugs, pots, vases and other wares that will adorn your living room. The innovative designs and art pieces are truly worth a look; so go ahead and visit the Craftsman House soon.




Located right across the street from Busch Gardens Tampa Bay, Adventure Island’s 30 acres of water-drenched fun in the sun features the ultimate combination of high-speed thrills and tropical, tranquil surroundings for guests of all ages. Within a soothing Key West atmosphere await slides, corkscrews, water falls, a wave pool, children’s water playground and other family attractions.




At Busch Gardens, animals roam free and you are the outsider. You can see the park by monorail, cable car or train. Roller coasters, wild animals, entertaining shows, rides, food, shopping, sightseeing, bird shows, exotic flowers, train rides, Serengeti adventures, river rapids...the list goes merrily on. Wear comfy walking shoes and spend the day at this 300-acre park. You can even taste the Anheuser Busch brew that started it all. Busch Gardens is open year-round with varying schedules. Call or see Web site for details.




The Florida Aquarium gives visitors an all-access pass to the mysteries of the deep. Observe seahorses, lobsters, colorful fish, moray eels, gators, river otters, Australian sea dragons and many more. If you're feeling truly adventurous, take advantage of the "Swim with the Fishes" or "Dive with the Sharks" programs (advance reservations required). Kids will love the wide range of colorful and fun-filled interactive displays. The aquarium also sponsors ecotours aboard a 64-foot catamaran, affording patrons an opportunity to get even more up-close-and-personal with the sea. See website for complete list of attractions, calendar of events and more.




This scenic village with its nautical heritage and waterfront location offers an assortment of shops, boutiques, restaurants, water sports and entertainment. Located near the sands of Madeira Beach, John's Pass Village is renowned throughout the Bay Area as a site of good crafts and artisans, as well as casually comfortable seafood eateries. Weekends, the Village puts its best fin forward with street shows that include plenty of musical entertainment. From its boardwalk and marina, you can enjoy a free dolphin watch or take off aboard small cruise ships and fishing charters.




Tampa's first zoo can trace its history back to the 1930s. In 1957, this collection of animals and birds was moved to its current location. Recognized as the "Number One Family-Friendly Zoo in the U.S." by Child magazine, Lowry Park Zoo features 2,000 animals on 56 acres of lush, natural habitats comprising seven main exhibit areas: Asian Gardens, Primate World, Free-Flight Aviaries, Florida Boardwalk, Florida Manatee and Aquatic Center, Wallaroo Station children's zoo, and Safari Africa. Gift shops, refreshment stands and cafes are located throughout the park.




If you've wondered how sun and wind supply power and water and how a host of other things work, this is the spot to find out. This environmental and educational center located at a 50-acre park is highly recommended not only for its low price, but also for its fine educational offerings. You can see a lake, upland forest and wetlands environment here and spot most of the plant and animal species native to this area. A mile-long nature trail winds through the park and an Interpretative Center features wildlife exhibits, displays, information, a classroom and a laboratory.






We need below information to serve you better

 

+1-888-717-2436

6201 America Center Drive Suite 240, San Jose, CA 95002, USA

Follow Us

facebook twitter linkedin youtube

 

Copyright © 2023 ComplianceOnline.com MetricStream
Our Policies: Terms of use | Privacy

PAYMENT METHOD: 100% Secure Transaction

payment method