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
10/10/2023 h. 09:00 - 17:00
11/10/2023 h. 09:00 - 17:00
Dr. Edelgard Rehak, Dr Edelgard Rehak Consulting, GERMANY

Michael Faust, EXTEDO GmbH, 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

ExpertFORUM Labelling

Online conference on digital, patient-friendly and safety labelling
dal 16/10/2023 al 17/10/2023
16/10/2023 h: 09:00 - 16:30
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

Robert Begnett, Kyow a Kirin International plc, Marlow , GREAT BRITAIN
  • 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
h. 09:00 - 17:00
Prof. Dr. Stephen Gilbert, Technische Universität Dresden, Dresden, Germany

ESQ., M.L.B., M.H.A Robert Lindner, Ada Health GmbH, Berlin, 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

CMC Management in Regulatory Affairs

Quality data for marketing authorisation in Europe
dal 24/10/2023 al 25/10/2023
24/10/2023 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

Dr. Helmut Vigenschow, ViPharmaService, Burgrieden
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.

  • 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
h. 09:00 - 17:00
Dr. Steffen Groß, Paul-Ehrlich-Institut (PEI), Langen

André Mota, ASPHALION S.L., Madrid Office, Spain

Dr. Helmut Vigenschow, ViPharmaService, Burgriede
- 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
dal 16/11/2023 al 16/11/2023
h. 09:00 - 17:30
Dr. Steffen Groß, Paul-Ehrlich-Institut (PEI), Langen

Dr. Michael Jandke, Miltenyi Biomedicine, Bergisch Gladbach

Dr. René Thürmer, - requested - Expert for Pharmaceutical Quality, Bonn, Germany
Get your know-how on creating and maintaining quality data for biotech products in our online training.

  • 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
05/12/2023 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

Dipl. BWL Guo Ning, Cisema Beijing Consulting Ltd.
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!

  • 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
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

Jill M. Browning, GREENBLUM & BERNSTEIN, P.L.C. Reston, Virginia, USA
  • 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
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

Mariangela Prada, Intexo Società Benefit Srl
  • 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
h. 09:00 - 17:00
Barbara Grossman, Hawkeye Medical Limited Medical Writing & Consultancy, Great Britain

Kirsten Sander, ARTIMED Medical Consulting GmbH, Kassel
  • 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
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
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
09:00 - 17:00
Dr. Christian M. Moers, Sträter Lawyers, Bonn, GERMANY

Reinhold Schilling, Wörwag Pharma GmbH & Co. KG, Boeblingen, 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
09:00 - 17:00
Mara Dinkel, Senior Expert Pharmacovigilance, Mainz, GERMANY

Heike von Treichel, Senior Expert Pharmacovigilance, Darmstadt, 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