Requirements 25 Veranstaltungen

PREFERRED

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

PREFERRED

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

PREFERRED

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

PREFERRED

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

PREFERRED

Produktmanagement Online Seminar: Technisches Produktmanagement mit Zertifizierung

proProduktmanagement GmbH (1)

In der Online Schulung Technisches Produktmanagement lernen Sie mit Hilfe unseres Requirements-Bewertungs-Schemas wie Sie Ihren Requirements-Prozess optimieren. Ganz gleich, ob Ihre Teams nach dem iterativen Entwicklungsprozess wie Agile oder dem tra...

• Webinar
• Ohne Einstufung

• 15.05.2024, Nürnberg (DE)
• weiterer Termin verfügbar

PREFERRED

Produktmanagement Seminar: Technisches Produktmanagement mit ToolBox inkl. Zertifizierung

proProduktmanagement GmbH (1)

In der Online Technisches Produktmanagement lernen Sie mit Hilfe unseres Requirements-Bewertungs-Schemas wie Sie Ihren Requirements-Prozess optimieren. Ganz gleich, ob Ihre Teams nach dem iterativen Entwicklungsprozess wie Agile oder dem traditionell...

• Seminar / Kurs
• Ohne Einstufung

• 15.05.2024, Nürnberg (DE)
• 3 weitere Termine verfügbar

PREFERRED

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

PREFERRED

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

PREFERRED

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

PREFERRED

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

PREFERRED

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

PREFERRED

GxP-Regulated Archiving

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

PREFERRED

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

PREFERRED

Produktmanagement Seminar: Strategisches + Technisches Produktmanagement mit ToolBox inkl. inkl. Zertifizierung

proProduktmanagement GmbH (1)

Kurskombination Strategisches Produktmanagement + Technisches Produktmanagement Unsere Lehrbücher für das Strategische und Technische PM sind auf unserer Webseite frei verfügbar und können kostenlos heruntergeladen werden. Damit eignen Sie sich zuhau...

• Seminar / Kurs
• Ohne Einstufung

• 13.05.2024 - 15.05.2024, Nürnberg (DE)
• 3 weitere Termine verfügbar

PREFERRED

Preparing for Mid-Term Review - Maximizing Impact and Planning Ahead

FORUM Institut für Management GmbH (147)

- Shifting allocations effectively within your programme - How to embed ´Strategic Technologies for Europe Platform´ (STEP) - Innovation Fund and Solidarity and Emergency Aid Reserve - Mid-term review of the ESIF programmes and reprogramming of the f...

• Seminar / Kurs
• Ohne Einstufung

• 27.05.2024 - 28.05.2024, Heidelberg (DE)

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

PREFERRED

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

PREFERRED

e-Learning: Stability Testing in the ICH Region - Stability testing for chemical and biological products in the ICH region

FORUM Institut für Management GmbH (147)

- Module 1: Regulatory requirements - Module 2: Factors that influence stability testing - Module 3: Stability test requirements - Module 4: Bracketing and matrixing - Module 5: Shelf life and extrapolation - Challenges - Module 6: Impact of changes...

• E-Learning
• Ohne Einstufung

• On Demand