Eventi Internazionali
Corsi di formazione in lingua Inglese su tematiche di respiro internazionale, organizzati dal nostro partner di formazione, il Forum Institut für Management GmbH. Gli speaker prescelti hanno provenienza europea.
Elenco corsi
Regulatory and GMP compliance in Eastern Europe
Considerations for the EAEU and Non-EAEU markets
dal 10/10/2023 al 11/10/2023
Online
10/10/2023 h. 09:00 - 17:00
11/10/2023 h. 09:00 - 17:00
11/10/2023 h. 09:00 - 17:00
Dr. Edelgard Rehak, Dr Edelgard Rehak Consulting, GERMANY
- EAEU pharmaceutical market and Non-EAEU markets: Regulatory Status quo
- Registration of New Drugs in the EAEU
- Variations in the EAEU
- CMC documents for Marketing Authorisation
- ... and many more topics
- Registration of New Drugs in the EAEU
- Variations in the EAEU
- CMC documents for Marketing Authorisation
- ... and many more topics
ExpertFORUM Labelling
Online conference on digital, patient-friendly and safety labelling
dal 16/10/2023 al 17/10/2023
Online
16/10/2023 h: 09:00 - 16:30
17/10/2023 h: 09:00 - 13:00
17/10/2023 h: 09:00 - 13:00
Dr. Peter Bachmann, -requested- Senior Expert Regulatory Affairs, Bonn
Kim Sherw ood, Medical Products Agency (MPA), Uppsala, SWEDEN
Nina Malvik, Norwegian Medicines Agency, Oslo, NORWAY
Dr. Rüdiger Faust, UCB BIOSCIENCES GmbH, Monheim, GERMANY
Dr. Jörg Fuchs, PAINT-Consult®, Jena, GERMANY
Dr. Thomas Grüger, -requested- Senior Expert Pharmacovigilance, Bonn, GERMANY
Olga Kolcak, Bayer Consumer Care AG, Basel, SWITZERLAND
- Impact of EU pharmaceutical legislation on drug labelling
- Patient information in the digital age: Latest achievements in ePI and the use of AI
- How to achieve patient-friendly package leaflets
- Labelling compliance during product life cycle: National and global perspectives
- Pharmacovigilance: Current requirements and trends for labelling and educational material
Crash Course: Medical Device Regulation
Insights into the applicability and general structure of the MDR
dal 19/10/2023 al 19/10/2023
Online
h. 09:00 - 17:00
Prof. Dr. Stephen Gilbert, Technische Universität Dresden, Dresden, Germany
- Overview of the Medical Device Regulation
- Responsibilities of the various parties
- Quality management system requirements (ISO 13485)
- General safety and performance requirements (GSPR)
- Technical documentation and CE certification
- Post-market surveillance: vigilance, PMCF and reporting
- Responsibilities of the various parties
- Quality management system requirements (ISO 13485)
- General safety and performance requirements (GSPR)
- Technical documentation and CE certification
- Post-market surveillance: vigilance, PMCF and reporting
CMC Management in Regulatory Affairs
Quality data for marketing authorisation in Europe
dal 24/10/2023 al 25/10/2023
Online
24/10/2023 h. 09:00 - 17:00
25/10/2023 h. 09:00 - 17:00
25/10/2023 h. 09:00 - 17:00
Dr. Margit Schnee, Vifor Pharma
André Mota, ASPHALION S.L., Madrid Office, Spain
This online training will give you in-depth knowledge on the CMC requirements for marketing authorisation. Take the chance to participate in our virtual seminar and get qualified.
Topics
- 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 variations
Integrated product development
from QbD (ICH Q8) to designed product lifecycle management (ICH Q12)
dal 14/11/2023 al 14/11/2023
Online
h. 09:00 - 17:00
Dr. Steffen Groß, Paul-Ehrlich-Institut (PEI), Langen
André Mota, ASPHALION S.L., Madrid Office, Spain
- From QbD (ICH Q8) to designed lifecycle management (ICH Q12): How to make the most of ICH
Q12 opportunities
- Special considerations and challenges for biologics
- ICH Q8 and ICH Q11: Mastering QbD concepts
- ICH Q9 and Q10: "Tools" to implement QbD
- ICH Q12: Interpretation and implementation
Q12 opportunities
- Special considerations and challenges for biologics
- ICH Q8 and ICH Q11: Mastering QbD concepts
- ICH Q9 and Q10: "Tools" to implement QbD
- ICH Q12: Interpretation and implementation
CMC for Biologicals
With a focus on proteins
dal 16/11/2023 al 16/11/2023
Online
h. 09:00 - 17:30
Dr. Steffen Groß, Paul-Ehrlich-Institut (PEI), Langen
Dr. Michael Jandke, Miltenyi Biomedicine, Bergisch Gladbach
Get your know-how on creating and maintaining quality data for biotech products in our online training.
Topics
- 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 included in the dossier, which not?
Masterclass China
Medical Device Marketing Authorisation for Advanced
dal 05/12/2023 al 06/12/2023
Online
05/12/2023 h. 09:00 - 12:00
06/12/2023 h. 09:00 - 12:00
06/12/2023 h. 09:00 - 12:00
Dipl.-Ing. Stefan Fischer, Cisema (Hong Kong) Limited
BA/LLB, RAC Hamish King, Cisema (Hong Kong) Limited
Would you like to successfully resist on Chinese market for medical devices? Then attend our webcasts and learn more about the new Chinese regulation for medical devices, how to perfect your pre-market registration and post-market surveillance: Our local experts will provide you with brandnew information!
Topics
- Update your regulatory knowledge
- Pre-Market Registration (PMR): Minimalise your efforts and costs
- Acceptance of European registration tests
- Clinical pathways: From feasibility study report to a clinical trial
- Perfect your cooperation with your NMPA legal agent
- Chinese IFU and label
Navigating the US pharmaceutical market - strategies for a successful launch
dal 06/12/2023 al 14/12/2023
Online
13:00 - 16:00
Randall J. Acosta, U.S. Pharma Consulting (USPC), USA
John W.M. Claud, Hyman, Phelps & McNamara, P.C., Washington D.C. Mark Kastner, SIMON-KUCHER & PARTNERS, Boston
Dr. Simone Seiter, Simon - Kucher & Partners, Frankfurt
- Understanding how the US healthcare system differs from other global markets
- Understanding US drug launch strategies and product planning as it pertains to the US regulatory drug development pathway
- Pricing and reimbursement strategies - impact of the Inflation Reduction Act (IRA)
- Marketing campaigns in line with compliance guidelines
- Intellectual property and patent considerations
- Important steps in project management
EU HTA: National preparation in France, Italy, Spain and UK
Part 3
dal 13/12/2023 al 13/12/2023
Online
09:00 - 13:00
Dr. Thomas Ecker, Ecker + Ecker GmbH, Hamburg
Alain Estival, Cemka, France
Christian Hill, MAP Patient Access, Cambridge, GREAT BRITAIN
Luis Lizán, Outcomes 10, Spain
- EU HTA: State of preparation and influence from a UK perspective
- EU HTA: Alignment with national HTA processes in France, Spain and Italy
- National scientific consultation on the HTA
Scientific Medical Writing for Medical Devices
Mastering Key Elements of Effective Scientific Writing
dal 13/12/2023 al 13/12/2023
Online
h. 09:00 - 17:00
Barbara Grossman, Hawkeye Medical Limited Medical Writing & Consultancy, Great Britain
- Understanding the purpose and goals of scientific writing
- Writing for medical devices: audience and purpose
- Systematic literature searches and writing an abstract
- Reviewing and Editing - Proofreading tips and tools
Generic Drugs: Market Access and Pricing in Europe
Germany, France, Italy, Spain, UK
dal 23/01/2024 al 23/01/2024
Online
09:00 - 17:00
Peter Wittner, Interpharm Consultancy, Raanana, Israel
Raphael Reitmeyer, Viatris Pharma GmbH
- Overview of European generic drug markets - similarities and differences
- A more detailed look at Germany, France, Italy, Spain and UK
- Generic tenders
- Reference pricing
- Role of parallel imports
CMC Writing
Update your CMC writing skills - with practical examples and exercises!
dal 07/02/2024 al 07/02/2024
Online
09:00 - 17:00
Dr. Christina Juli, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany
Dr. Jakob Engel, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany
Joel Walderbach, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany
Katrin Bräckow, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany
- Structure and presentation of Module 3 and Module 2 (Quality Overall Summary)
- CTD sections in detail: S-Part, P-Part, specific sections
- Country specific requirements, e.g. China, Japan, Brazil, etc.
- Considerations for small and large molecules
The EU Qualified Person for Pharmacovigilance (EU QPPV)
Refresher of the duties and responsibilities of a QPPV
dal 21/02/2024 al 21/02/2024
Online
09:00 - 17:00
Dr. Christian M. Moers, Sträter Lawyers, Bonn, GERMANY
- Legal basis for the EU QPPV
- Regulatory requirements for practice
- Networking and integrating an EU QPPV across the company
- Liability and legal protection
The Pharmacovigilance System Master File (PSMF) in a Global Environment
Core PSMF vs local annexes: Dos and Don'ts
dal 26/02/2024 al 26/02/2024
Online
09:00 - 17:00
Mara Dinkel, Senior Expert Pharmacovigilance, Mainz, GERMANY
- Concept of a global PSMF
- Structure and content of a core PSMF
- Local annexes - practical hints and pitfalls
- Effective maintenance: Impact assessment, ad-hoc updates and change control
- QPPV oversight vs. local PV officer