your 33 Veranstaltungen

Verwandte Suchbegriffe: wird geladen ...

PREFERRED

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

PREFERRED

FORUM Institut für Management GmbH (147)

- Gesetzliche Rahmenbedingungen (GwG, BaFin Auslegungs- und Anwendungshinweise, TraFinG Gw u.w.) und aktuelle Entwicklungen mit Relevanz für die KYC-Unit - Sorgfaltspflichten im Überblick - Identifikation der Vertragspartner und weiterer Rollen - Erm...

  • Webinar
  • Ohne Einstufung

PREFERRED

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

PREFERRED

FORUM Institut für Management GmbH (147)

- Update your regulatory knowledge - Pre-Market Registration (PMR): Minimalise your efforts and costs - Acceptance of European registration tests - Clinical pathways: From feasibility study report (FSR) to a clinical trial - Post-market Surveillance...

  • Webinar
  • Ohne Einstufung

PREFERRED

FORUM Institut für Management GmbH (147)

- General claim drafting tips - Claim categories - Identifying and claiming the technical invention - Other parts of the specification - Practice test Learn how to write digital patent applications which get granted and are infringed upon! This onlin...

  • Webinar
  • Ohne Einstufung

PREFERRED

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

PREFERRED

FORUM Institut für Management GmbH (147)

- Understanding artificial intelligence: ML, NLP, LLM and more - Legal background and future developments - Trends in pharmacovigilance technology - AI in PV: Current position and future possibilities - Management perspectives and compliance - Practi...

  • Webinar
  • Ohne Einstufung

PREFERRED

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

PREFERRED

FORUM Institut für Management GmbH (147)

- Essentials of FTO: what it is, when to do it and how much does it cost - FTO Search: strategies and scope - Drafting FTO opinions - Taking action: protective letters and more - Added value of FTO: reusing the results - Evaluating search results: in...

  • Webinar
  • Ohne Einstufung

PREFERRED

FORUM Institut für Management GmbH (147)

Our global and local experts will update you every two months with the latest regulatory and legislative developments. Thus, you will always have the essential information and trends in regulatory affairs at your fingertips!

  • Webinar
  • Ohne Einstufung

PREFERRED

FORUM Institut für Management GmbH (147)

- Know your customer - (gerade) bei juristischen Personen - Identifizierung von juristischen Personen - Fallstricke und Lösungen - Identifizierung der beteiligten Akteure im Investmentbereich - Exkurs: Juristische Personen in Gruppen verbundener Kund...

  • Webinar
  • Ohne Einstufung

PREFERRED

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

PREFERRED

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

PREFERRED

FORUM Institut für Management GmbH (147)

- Risikokategorien und Quality by Design in klinischen Prüfungen - Wrap-up der Regularien: Die Vorgaben von FDA, EMA, ICH & Co. - Risikomanagement in der Unternehmenspraxis: Werkzeuge zum Risikomanagement - Its your turn! Erarbeitung des Risikomanage...

  • Webinar
  • Ohne Einstufung

PREFERRED

FORUM Institut für Management GmbH (147)

- Bedeutung von Legal Innovation - Einsatz von Tech-Tools des Unternehmens in der Rechtsabteilung - Praxisbeispiel: Effektives Knowledge-Management - Einsatz von Ticketing-Systemen und Self-Service Dashboards - Agile Arbeitsmethoden - Know your custo...

  • Webinar
  • Ohne Einstufung

PREFERRED

FORUM Institut für Management GmbH (147)

- Selection of case-law from the different UPC divisions - Disputed case-law: How to assess diverging decisions - Detailed presentation of the cases and their impact on your legal practice - Written summaries of the relevant decisions - Access to re...

  • Webinar
  • Ohne Einstufung

PREFERRED

FORUM Institut für Management GmbH (147)

- The potential of generative AI for daily patent work - Generative AI in patent search - Improved portfolio management with generative AI - Generative AI in patent drafting and prosecution - Invalidation with generative AI - How to implement gen...

  • Webinar
  • Ohne Einstufung

PREFERRED

FORUM Institut für Management GmbH (147)

- Market potential for European companies in the Chinese market - Product approval - National Medical Products Administration (NMPA): Documents, procedures, fees - tips and tricks - Clinical pathways - Post-market Surveillance & Quality Management Sy...

  • Webinar
  • Ohne Einstufung

PREFERRED

FORUM Institut für Management GmbH (147)

- Key issues in a patent due diligence - Process, milestones and strategies - Evaluating a patent due diligence: due diligence reports, typical risks, how to minimise the risks - IP provisions in acquisition contracts - Dos and donts in a patent due...

  • Webinar
  • Ohne Einstufung

PREFERRED

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