EMA has a 20-year track record of ensuring efficacy and safety of human and veterinary medicines across Europe, and promoting research and innovation in the development of medicines. In its first two decades, the Agency recommended the authorization of a total of 975 human and 188 veterinary medicines.

1. 2-day In-person Seminar:
Knowledge, a Way Forward…
Zurich, Switzerland
August 28th & 29th, 2017
9:00 AM to 6:00 PM
David R. Dills
Price: $1,695.00
(Seminar for One Delegate)
Register now and save $200. (Early Bird)
**Please note the registration will be closed 2 days
(48 Hours) prior to the date of the seminar.
Price
Overview :
Global
CompliancePanel
David R. Dills, Global Regulatory Affairs &
Compliance Consultant currently provides regulatory affairs and
compliance consultative services for early-stage and established Class
I/II/III device, IVD, biopharmaceutical, cosmetics and nutraceutical
manufacturers on the global landscape, and has an accomplished
record with more than 27 years of experience in the areas of
Regulatory Affairs, Compliance and Quality Systems. He has been
previously employed, with increasing responsibilities by device
manufacturers and consultancies, including a globally recognized CRO
and has worked directly with manufacturers engaged in compliance
remediation activities involving consent decrees, CIA's, warning letters,
and customer generated compliance events, conducts QS, regulatory,
compliance assessments/audits and FDA Mock Inspections for State
of Readiness.
EMA has a 20-year track record of ensuring efficacy and safety of
human and veterinary medicines across Europe, and promoting
research and innovation in the development of medicines.
In its first two decades, the Agency recommended the authorization
of a total of 975 human and 188 veterinary medicines.
EMA's success is based on cooperation within the European
medicines regulatory network - a unique partnership between the
European Commission, the medicines regulatory authorities
$8,475.00
Price: $5,085.00 You Save: $3,390.0 (40%)*
Register for 5 attendees
Global Regulatory Affairs & Compliance Consultant

2. 2-day In-person Seminar:
European Regulatory Affairs Process with EMA and other
Regulatory Authorities
Global
CompliancePanel
Agenda:
Day One Day Two
Lecture 1: EMA and Regulatory Overview and Pathways
 Introductions and Background
 Legal Basis for the European Regulation of Medicinal
Products
 EU Pharmaceutical Legislation Overview
 Review of the key EU Directives and Regulations
 Legal and Regulatory basis of marketing authorization
applications
 Main features of the EU Marketing Authorization (MA)
process and next steps
 How the EMA, EU institutions and individual national
health authorities interact
 Identify and describe the scope, operation and
management of the Centralized Procedure (CP) and
other aspects of the CP
 Mutual Recognition (MRP) and Decentralized Procedure
(DCP) and factors directly influencing the choice of
procedure and your regulatory pathway
 MRP is based on the mutual recognition by CMSs of a
national MA granted by a RMS
 DCP is available for new products which have not yet
been authorized in any EEA country and do not fall
within the mandatory scope of the CP
 Review and navigation of key EU regulatory websites
 European Commission (EC), EMA and interrelationship
with European Directorate for the Quality of Medicines
(EDQM)
 National Competent Authorities and interactions with
other regulatory bodies
 Regulatory Pathways to consider regarding the
Centralized Procedure
 Prepare and handle effective Consultations with EMA
and your pre-submission activities
 Managing your procedural phases up to acceptance of
the final CHMP opinion and preparing for next steps in
the regulatory process
 Interactive Discussions
 Review of Regulatory Documents
Lecture 2: Exercise and Recap of Day 1
 Interactive Discussions
 Review of Regulatory Documents
 Recap of topics and key discussion points and take
away message
 FAQs and latest trends
Lecture 1: EMA and Agencies
 Reviewing and addressing Decentralized and Mutual
Recognition Procedures
 Main features and attributes as well as differences of
DCP and MRP
 Addressing Variations to the EU Marketing Authorization
and Post-Approval Changes
 Overview and vital elements of the variations procedure
and dealing with implementing guidelines and other
materials
 EU Regulatory Innovations for Specific Groups of
Products and having a viable regulatory pathway for
Orphan Drugs, Herbal Medicinal products and others
 Developing trends and the short and long-term impact
on the EU pharmaceutical registration process
 Accelerated Assessments and Conditional Approvals
and other Considerations
Lecture 2: Exercise and Recap of Day 2
Lecture 3: Debrief/Adjourn

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What You will get
Special price on future seminars by
GlobalCompliancePanel.
Networking with industry's top notch professionals
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1 Learning Objectives
2 Participation certificates
Interactive sessions with the US expert
Post event email assistance to your queries.
Special price on future purchase of web
based trainings.
Special price on future consulting or expertise
services.
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Seminar Kit – includes presentation handout,
ID card, brochure, trainings catalog, notepad
and pen.
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Toll free: +1-800-447-9407
Fax: 302 288 6884
Email: support@globalcompliancepanel.com
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Global
CompliancePanel
2-day In-person Seminar:
European Regulatory Affairs Process with EMA and other
Regulatory Authorities