with 47 Veranstaltungen

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

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

PREFERRED

Generative AI (incl. ChatGPT) for Patent Practitioners

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

• 04.07.2024

PREFERRED

The IP Strategist - Toward proactive and aligned management of innovation and IP

FORUM Institut für Management GmbH (147)

- Explore further the matrix-approach for strategy making, with advanced techniques (using Excel) - Learn new methodology to (re)align the IP portfolio with the business focus. Link IP to financials and business strategy. - Apply and present these tw...

• Seminar / Kurs
• Ohne Einstufung

• 10.06.2024 - 12.06.2024, München (DE)

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

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

Agile meets IP - How to implement agile tools in IP departments

FORUM Institut für Management GmbH (147)

- Agile - history & basics - what is it and where does it come from? - Agile methodologies and tools - Serious Agile IP Game: developing a monovariate patent evaluation method with agile methods - A continuous improvement in IP departments - a practi...

• Webinar
• Ohne Einstufung

• 24.10.2024

PREFERRED

The UPC Case Management System for European Patent Litigators

FORUM Institut für Management GmbH (147)

- Using the CMS: managing accounts, authentication, roles, representatives, and teams; Opt-out - Managing infringement and revocation proceedings, appeals and related proceedings - Dealing with the court: dates, documents, payments, languages - Case...

• Webinar
• Ohne Einstufung

• 10.06.2024 - 11.06.2024

PREFERRED

The UPC Case Management System for Paralegals

FORUM Institut für Management GmbH (147)

- Using the CMS: managing accounts, authentication, roles, representatives, and teams; Opt-out - Managing infringement and revocation proceedings, appeals and related proceedings - Dealing with the court: dates, documents, payments, languages - Case...

• Webinar
• Ohne Einstufung

• 13.05.2024 - 14.05.2024

PREFERRED

IP Management in Practice - Gain key concepts, skills and tools from experienced IP Managers

FORUM Institut für Management GmbH (147)

- Essentials of IP Management - IP & Strategy. IP & Innovation - Patent Portfolio Management - FTO & Patent Clearance - IP & Valuation - IP & Licensing. IP & Litigation - Future of IP Management The IP Management in Practice online course was develop...

• Webinar
• Ohne Einstufung

• 15.10.2024 - 15.11.2024

PREFERRED

The basics of auditing EU Funds

FORUM Institut für Management GmbH (147)

- EU regulatory framework - Different types of audits and their scope - Thematic audits - IT systems and databases - Output of the work of the Audit Authority and cooperation with other authorities Wondering how to navigate the complexities of EU Fu...

• Webinar
• Ohne Einstufung

• 19.09.2024

PREFERRED

IP Strategist - Toward proactive, aligned and long-term management of innovation and IP

FORUM Institut für Management GmbH (147)

- Gain knowledge, tools and skills based on research, practice, and industry examples - Prioritization: where to spend resources and focus IP activities (under budget constraints) - (Re)align the IP portfolio with the business focus. Link IP to finan...

• Webinar
• Ohne Einstufung

• 04.06.2024 - 18.06.2024

PREFERRED

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

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)

PREFERRED

PharmaFORUM Webcast International - Marketing Authorization in the USA 5 November 2024

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

• 01.11.2024 - 31.10.2025

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

Current Medical Affairs Trends 2024 - Opportunities of digitalization - today and tomorrow

FORUM Institut für Management GmbH (147)

- Medical Affairs - the new strategic role in a digital world - How to generate and analyze Insights (using AI) - Use cases of Medical data meeting AI - Omnichannel communication with KOL - Scientific or educational storytelling to HCPs and public Di...

• Webinar
• Ohne Einstufung

• 23.05.2024

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

IP Agreements: Research and Development Agreements

FORUM Institut für Management GmbH (147)

- Contract research and R&D cooperation - Cooperation with universities - IP transfer - Non disclosure agreements - Choice of law, jurisdiction, arbitration clauses - R&D Agreements interactive workshop Participants, doing business in a complex multi...

• Webinar
• Ohne Einstufung

• 23.10.2024

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