Requirements 25 Veranstaltungen

PREFERRED

IREB CPRE Requirements Engineering Foundation

mITSM GmbH (26)

IREB CPRE Requirements Engineering Foundation In der dreitägigen Schulung erwirbst du grundlegendes Wissen im Bereich Requirements Engineering. Das Training behandelt Aspekte wie das angemessene Dokumentieren von Anforderungen, die Verifikation und V...

• Seminar / Kurs
• Grundlagen

• 12.08.2024 - 14.08.2024, München (DE)
• weiterer Termin verfügbar

PREFERRED

IREB CPRE Requirements Engineering Foundation (Online)

mITSM GmbH (26)

IREB CPRE Requirements Engineering Foundation In der dreitägigen Schulung erwirbst du grundlegendes Wissen im Bereich Requirements Engineering. Das Training behandelt Aspekte wie das angemessene Dokumentieren von Anforderungen, die Verifikation und V...

• Webinar
• Grundlagen

• 22.05.2024 - 24.05.2024
• 3 weitere Termine verfügbar

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Pharmacovigilance Requirements in China - LATAM - EAEU - MENA - 5 webcasts in two days: Legal framework, Country-specific requirements and more

FORUM Institut für Management GmbH (147)

- Legal framework in selected (emerging) countries or regions - Similarities and differences in ADR collection and reporting compared to EMA standards - Country-specific requirements for PSMF, PSURs and RMPs - How to integrate local PV systems into a...

• Webinar
• Ohne Einstufung

• 10.06.2024 - 11.06.2024

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U.S. Patent Formalities - The Guide to the Formal Requirements

FORUM Institut für Management GmbH (147)

- What are relevant law, rules and guidelines? - Useful USPTO resources, including Patent Center and Global Dossier - Requirements and formal documents for a U.S. patent application - Workshop: Example filing of patent application, documents and amen...

• Webinar
• Ohne Einstufung

• 02.07.2024

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Advanced PCT Formalities Summer Course - Goal-oriented Guide to the Formal Requirements

FORUM Institut für Management GmbH (147)

- Influencing procedure with formality actions - Avoiding filing defects, reducing administration during national phases and problems during search and examination - Improving quality and speed of patentability opinions - Increasing value of applicat...

• Webinar
• Ohne Einstufung

• 11.07.2024 - 12.07.2024

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CMC dossier requirements for biologics: FDA vs EU - Marketing Authorisation of large molecues in the US with a focus on CMC

FORUM Institut für Management GmbH (147)

- Regulatory landscape in the US - Scientific advice - The IND and BLA procedure - Post-approval/maintenance: Procedures and documentation - Quality data for marketing authorisation - Case studies CMC requirements in the US: After having attended the...

• Webinar
• Ohne Einstufung

• 23.10.2024

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CMC Management in Regulatory Affairs - Quality data for marketing authorisation in Europe

FORUM Institut für Management GmbH (147)

- Regulatory requirements in the EU and the ICH region - Essential quality data for marketing authorisation - CMC documentation: Module 3, ASMF, CEP and Quality Overall Summary - Management of post-approval changes - Classification of quality related...

• Webinar
• Ohne Einstufung

• 12.11.2024 - 13.11.2024

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Mastering FDA inspections: Preparation and Best Practices - Efficient and effective preparation strategies

FORUM Institut für Management GmbH (147)

- Key regulatory requirements - How to prepare in advance? - Special considerations in FDA inspections - Follow-up: What you need to pay attention to - Avoiding FDA 483s, handling warning letters FDA inspection readiness: Gain the knowledge and skill...

• Webinar
• Ohne Einstufung

• 15.10.2024

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CMC for Biologicals - With a focus on proteins

FORUM Institut für Management GmbH (147)

- Regulatory framework: ICH guidelines - Essential data for biologics for Module 3 - Challenges in Module 3: Focus on antibodies, immunoglobulins and recombinant proteins - Comparability requirements for changes - Critical data: Which data must be in...

• Webinar
• Ohne Einstufung

• 04.11.2024

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Marketing Authorisation in Latin America - Online seminar with a focus on: Brazil, Mexico, Argentina, Colombia, Chile, Peru

FORUM Institut für Management GmbH (147)

- LatAm - regulatory environment and harmonisation trends - National procedures in Brazil, Mexico, Argentina, Colombia, Chile, Peru - Dossier requirements for NCEs and generics - Maintenance: variations and renewal - Bring your own cases! An online s...

• Webinar
• Ohne Einstufung

• 26.09.2024 - 27.09.2024

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An Introduction for Pharmacovigilance Managers - Start your career in Drug Safety

FORUM Institut für Management GmbH (147)

- Regulatory framework and EMA GVP modules - Management of side effects and signals - Benefit-risk assessment and risk management - Important pharmacovigilance documents - Interfaces with other departments and quality management Are you new to pharma...

• Webinar
• Ohne Einstufung

• 12.11.2024 - 13.11.2024

PREFERRED

PharmaFORUM Webcast Biologics 2024

FORUM Institut für Management GmbH (147)

- Statistical aspects in the validation of bioanalytical methods - Quality requirements for biologics in clinical studies: Clinical trials vs. marketing authorization - New clinical trial designs - Vendor oversight in a functional outsourcing concept...

• Webinar
• Ohne Einstufung

• 01.12.2024 - 30.11.2025

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GxP-Regulated Archiving - How to act in compliance with GMP/GLP/GCP

FORUM Institut für Management GmbH (147)

- Compliance requirements within the GMP, GLP, and GCP framework in the pharmaceutical sector - Audit security, electronic archiving, outsourcing - Customized case study workshop: giving priority to your real-life cases - Audits and inspection of arc...

• Webinar
• Ohne Einstufung

• 24.09.2024

PREFERRED

Medical Writing in Pharmacovigilance - Update your PV writing skills with many exercises!

FORUM Institut für Management GmbH (147)

- Pharmacovigilance Writing: Best practices, common pitfalls, and cultural challenges - PV documents in the life cycle of a medicinal product: DSUR, RMP, and PSUR - Safety concerns and their use in PV documents - Role of the pharmacovigilance writer...

• Webinar
• Ohne Einstufung

• 06.06.2024 - 07.06.2024

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RMP and PSUR in lifecycle management: An art, not a miracle - The advanced course in Risk Management

FORUM Institut für Management GmbH (147)

- The role of RMP and PSUR in the drug lifecycle - Writing pharmacovigilance documents - QPPV oversight - Impact of EU assessment reports on RMPs and PSURs - Effective global management and harmonisation of RMPs and PSURs - Additional risk minimisati...

• Webinar
• Ohne Einstufung

• 06.11.2024

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Webcast series Technical development of RNA-based drugs and oligonucleotides - Critical aspects of non-clinical and CMC drug development, analytics, m

FORUM Institut für Management GmbH (147)

- Concept: Five weekly live webcasts à 2 hours with longtime experienced speakers - Topics covered: Non-clinical aspects, principles and challenges during drug development, regulatory requirements, CQA and analytical tools, formulation - Your benefit...

• Webinar
• Ohne Einstufung

• 11.09.2024 - 11.12.2024, Online (DE)

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ISO 27001 Foundation - English

mITSM GmbH (26)

ISO 27001 Foundation – English Content In our ISO 27001 Foundation training, you will learn the basics of information security management according to the international standard ISO/IEC 27001. The following content awaits you: Introduction to informa...

• Seminar / Kurs
• Grundlagen

• 15.05.2024 - 16.05.2024, München (DE)
• 2 weitere Termine verfügbar

PREFERRED

ISO 27001 Foundation - English

mITSM GmbH (26)

ISO 27001 Foundation – English Content In our ISO 27001 Foundation training, you will learn the basics of information security management according to the international standard ISO/IEC 27001. The following content awaits you: Introduction to informa...

• Webinar
• Grundlagen

• 27.06.2024 - 28.06.2024
• 2 weitere Termine verfügbar

PREFERRED

e-Learning: CTD Module 3 - Data requirements in the EU

FORUM Institut für Management GmbH (147)

- CTD structure and applicable guidelines - Drug substance Part - ASMF and CEP - Drug product part This e-Learning programme will familiarise you with the data requirements in CTD Module 3.

• E-Learning
• Ohne Einstufung

• On Demand

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e-Learning: Common Technical Document and eCTD - including CMC requirements for marketing authorisation applications

FORUM Institut für Management GmbH (147)

- CTD principles and structure - Format and content of Module 1 - 5 CTD - CMC data required for Module 3 (drug substance and drug product) - Dossier requirements for generics and further abridged procedures - Dossier requirements for ASMF and CEP sub...

• E-Learning
• Ohne Einstufung

• On Demand