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Seminar 2: Regulatory Procedures for clinical trial applications, marketing authorisations, variations in the EU, USA, Japan, Switzerland and China


Course Description

CONTENT

Seminar 2 provides in-depth knowledge on the procedures for marketing authorization applications, clinical trial authorisations and variations in the EU, USA, Japan, Switzerland and China. These regions are the most important markets for pharmaceutical products and the appropriate agencies such as the European national agencies, the EMA, the FDA and the Japanese MHLW have major influence on the regulatory strategy in pharmaceutical companies used to develop and submit new medicines. In order to authorise products in these markets successfully companies need to act according to the requirements and procedures of the different regions since they are not harmonised despite increasing efforts. For the EU the centralised procedure and the national mutual recognition and decentralised procedures are described in detail. Furthermore the documentation and steps required to obtain and maintain authorisations for clinical trials are discussed. During the life cycle of products their marketing authorization dossier is changed and the changes are subject to regulatory processes. For biopharmaceuticals these variations are frequently demanding in terms of data and dossier requirements. The seminar focuses in detail on product life cycle activities related to Europe but also provides an overview on the principles to be followed in other regions.

- European centralized procedure at EMA
- MRP and DCP
- CTA in Europe – process, VHP, particulars for biopharmaceuticals
- Variations - changes to the CTD, procedures, data particulars for biopharmaceuticals
- Changes to the SmPC
- Approval in other regions - process and essentials of the relevant agencies

LEARNING OBJECTIVES

- Get in-depth knowledge on the European DCP, MRP and centralized procedures for Marketing Authorisation Applications (MAA)
- Understand the main responsibilities of the European Medicines Agency (EMA) and the details of the centralized procedure
- Understand the specific requirements of the authorization, clinical trial and post-authorisation procedures in the USA, Japan, Switzerland and China
- Understand and select the most appropriate registration procedure
- Manage the particulars of the nationally managed Clinical Trial Applications (CTA) successfully and understand the Voluntary Harmonisation Procedure for CTAs
- Delivers the details on the different types of variations valid for biopharmaceuticals
- Manage to install an effective life cycle system to prepare adequate documentations effectively and the procedures with time-lines successfully
- Identify which documentation and data are required for each type of variation

AGENDA

Day 1, Tuesday, 28 October 2014

09.15 - 09.30 Welcome and introduction (Connie van Oers, Xendo)

09.30 - 10.15 European Centralised Procedure at the EMA (Connie van Oers, Xendo)

1. Essentials on regulation and procedures

Mandatory and optional scope of the centralised procedure
Eligibility request
Pre-submission activities
Conditional marketing authorisation
Marketing authorisation under exceptional circumstances
Accelerated assessment
Appointment and role of the (Co) Rapporteurs and their assessment teams, of the EMEA PTL and of experts of agencies
Involvement of working parties and scientific committees other than CHMP

10.15 - 10.45 Coffee break

10.45 - 11.45 European Centralised Procedure at the EMA (Connie van Oers, Xendo)

1. Essentials on regulation and procedures

Review process
Procedure
Validation of the MAA
Time lines
Assessment report
CHMP Peer Review
Oral explanation
CHMP Opinion
Withdrawal
Re-examination
Commission decision
Life-cycle of European Marketing Authorisations
Actual marketing
Cessation of placing a product on the market
Suspension
Revocation
Withdrawal
“Renewal”
Sunset clause
Annual re-assessment

11.45 - 12.45 Lunch

12.45 - 13.45 continued (Connie van Oers, Xendo)

13.45 - 14.30 European Centralised Procedure at the EMA (Eric Abadie, Former CHMP Chairman, Euremed Consulting

Graham Higson, GCH Pharma Consulting Ltd)

2. Strategic aspects to be considered in the interaction with the EMA

14.30 - 15.00 Coffee break

15.00 - 16.30 continued

18.00 Get-together with food and wine

Day 2, Wednesday, 29 October 2014

08.30 - 10.30 USA (Matthew Klimek, F. Hoffmann-La Roche)

Legal basis for medicinal products and medical devices
Types and procedures of regulatory submissions
Role and function of and interaction with the FDA
The FDA’s review process
The Investigational New Drug Application (IND)
The New Drug Application (NDA)
The Biological License Application (BLA)
Accelerated development options
FDA’s approach to the CTD
Supplements and post-marketing obligations
Regulations for biopharmaceuticals, biosimilars and advanced therapies
Orphan drugs

10.30 - 11.00 Coffee break

11.00 - 12.30 The PDUFA process at FDA (Tilo Netzer, PharmaLex)

12.30 - 13.30 Lunch

13.30 - 15.00 Marketing Authorisation and Clinical Trial Authorisations Applications in other regions (focus on biopharmaceuticals) (Esther Imboden, Regulix)

15.00 - 15.30 Coffee break

15.30 - 17.30 European National Mutual recognition (MRP) and Decentralised Procedure (DCP) (Connie van Oers, Xendo)

Network and resources of the agencies: role and activities of the RMS, CMS, CMD(h)
Filing, validation, time lines, process management, fees
Review process
Assessment report
CMD(h) and CHMP referrals
Referral

Day 3, Thursday, 30 October 2014

09.15 - 10.30 The regulatory system in China (Susanne Szabo, Novartis)

Pharmaceutical legislation
Organisation of the S-FDA
Types and procedures of regulatory submissions
Pre-submission procedures
Clinical Trials
Regulations for biopharmaceuticals, biosimilars and advanced therapies
Orphan Drugs

10.30 - 11.00 Coffee break

11.00 - 12.00 continued

12.00 - 13.00 Lunch

13.00 - 15.00 Variations-European Regulations and national legal provisions for changes to the CTD (Kora Doorduyn- van der Stoep, MEB)

Classifications, documentation
Procedures and time lines
Contact points
Downgrading, pooling and consequential changes
Multiple agency submissions
Appeals

15.00 - 15.30 Coffee break

15.30 - 18.00 Changes to the Biotech CTD (Steffen Gross, PEI)

Data and documentation requirements
Typical changes and their evaluation
New approaches and challenges for changes and their handling

Day 4, Friday, 31 October 2014

09.15 - 10.30 Changes to the SmPC / Product Information (Ruth Rettenmeier, PAREXEL Consulting)

10.30 - 11.00 Coffee break

11.00 - 12.30 continued

12.30 - 13.30 Lunch

13.30 - 15.30 Japan (Benita von Glahn, Boehringer Ingelheim)

Pharmaceutical legislation in Japan
Organisation of and interaction with the MHLW
Types and procedures of regulatory submissions
Pre-submission procedures
Relevance of clinical bridging studies
KIKO consultation – Clinical Trial Notification (CTN)
Regulations for biopharmaceuticals, biosimilars and advanced therapies
Orphan Drugs

15.30 - 16.00 Coffee break

16.00 - 18.00 Clinical Trial Application (CTA) in Europe: legal basis and relevant procedure (Hartmut Krafft, PEI)

Entry Requirements

English language knowledge

Course Fees

2.800 EUR regular fee, 1.720 EUR for academic institutions/government (+19% German VAT)


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