Meetings/Workshops on Regulation in Medicine and Pharmacology in Germany

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Belgium (2) - Germany (6) - India (3) - Switzerland (1) - United Kingdom (2) - United States (20) - ALL COUNTRIES (34)

1
CfPIE - The Center for Professional Innovation & Education, Inc. — Computer System Validation
12 Apr 2018 - 13 Apr 2018 • Berlin, Germany
Abstract:
This computer system validation course focuses on developing and implementing regulated computer systems with an appropriate level of documented evidence to satisfy FDA expectations. The course targets deliverable document content and how to avoid rework and unnecessary expense through a proactive approach. The core elements of a satisfactory computer validation program will be emphasized.
Contact:
Olivia Carlin;     Phone: [1-610-648-7550];     Email: info@cfpie.com
Topics:
21 CFR part 11, computer validation, GAMP 5, Auditing GXP, Part 810, Part 211, Q7A GMPs, Software Validation
Event listing ID:
1009972
Related subject(s):
2
CfPIE - The Center for Professional Innovation & Education — Good Manufacturing Practices Training | GMP Course
18 Apr 2018 - 20 Apr 2018 • Berlin, Germany
Abstract:
This Good Manufacturing Practices training covers the foundations of the regulations that control the manufacture and distribution of pharmaceutical, biologic and medical devices sold in the United States. Current Good Manufacturing Practices (cGMPs) are defined for all Food and Drug Administration (FDA) Regulated products in Title 21 CFR 210/211. Application of the regulations will be discussed and examples provided throughout the GMP course. Attendees will gain an understanding of how knowledge of the regulations facilitates efficient and cost effective production and problem resolution.
Contact:
Olivia Carlin;     Phone: [1-610-648-7550];     Email: info@cfpie.com
Topics:
GMP, Change Control, Master Plan, Laboratory Controls
Event listing ID:
1010048
Related subject(s):
3
CfPIE - The Center for Professional Innovation & Education — CMC Regulatory Compliance for Biopharmaceuticals & Biosimilars
23 May 2018 - 25 May 2018 • Berlin, Germany
Abstract:
This course will help the attendee to develop a CMC regulatory compliance strategy for biopharmaceuticals, biosimilars and other biologics, addressing the five core elements that comprise an effective strategy: (1) embracing the full spectrum of CMC activities, (2) addressing unique requirements for specific biologic manufacturing processes, (3) addressing unique requirements for specific biologic products, (4) aligning with the strategic ICH Q8/Q9/Q10 guidances, and (5) applying a clinical phase-appropriate approach. The critical importance of communicating CMC regulatory compliance strategy with the regulatory authorities at CMC-focused meetings will be stressed. In addition, this course will also help the attendee to better understand the CMC regulatory compliance requirements for Quality by Design applications and for biosimilars.
Contact:
Olivia Carlin;     Phone: [1-610-648-7550];     Email: info@cfpie.com
Topics:
compliance, biologics, FDA, EMA, regulatory review pathways, IND, NDA, BLA, MAA
Event listing ID:
1010007
Related subject(s):
4
CfPIE - The Center for Professional Innovation & Education — Preparing the CMC Section for MAAs, IMPDs
30 May 2018 - 31 May 2018 • Berlin, Germany
Abstract:
This course includes an overview of the relevant guidelines and the organization of the CTD, detailed information and discussions related to each element required in the drug substance and drug product sections of MAAs. The course will emphasize the requirements related to drug substance starting materials, drug substance and drug product specifications, impurities, stability, manufacturing and pharmaceutical development. It will also discuss the use of Drug Master Files (DMF), Certificates of Suitability (CEPs) and preparation of the CTD Quality Overall Summary (Module 2).
Contact:
Olivia Carlin;     Phone: [1-610-648-7550];     Email: info@cfpie.com
Topics:
MAA, CTD, drug substance, purity, stability, DMF, Certificates of Suitability, CEP, CMC, chemistry manufacturing and controls
Event listing ID:
1009990
Related subject(s):
5
Course — European Regulatory Procedures - EMA & National Requirements
13 Sep 2018 - 14 Sep 2018 • Berlin, Germany
Abstract:
This course will give participants the necessary overview of the application procedures and regulatory filing pathways used within Europe to grant marketing authorisations for medicinal products, and of the agencies and institutions that control the regulatory process. Special focus will be given to the European Medicines Agency (EMA) and the Centralised Procedure (CP), with the role of the national health authorities and other EU bodies in the Mutual Recognition Procedure (MRP) and Decentralised Procedure (DCP) explained also. Factors affecting the choice of procedure will be discussed, as well as best practice in the management of the procedures. A workshop session will engage participants in a case study evaluating the options for submission of a marketing authorization application.
Contact:
Olivia Carlin;     Phone: [+1-610-648-7550];     Email: info@cfpie.com
Topics:
European Regulatory Procedures, Regulation, EMA, Centralised Procedure, European Medicines Agency, Filing Strategy, Labeling
Event listing ID:
1012439
Related subject(s):
6
Course — Filing Variations in the European Union
07 Nov 2018 - 08 Nov 2018 • Berlin, Germany
Abstract:
The course is designed to provide individuals with an in-depth awareness of the rules and procedures for filing variations and extensions. Understanding and applying the rules will ensure that you can file the variations successfully and avoid rejections.
Contact:
Olivia Carlin;     Phone: [+1-610-648-7550];     Email: info@cfpie.com
Topics:
filing, extensions, Marketing Authorizations, filing variations, CMD, Submission, Timeline
Event listing ID:
1012528

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AIP Conference Proceedings
AIP Conference Proceedings
Last updated: 07 February 2018