Affari Regolatori / Farmacovigilanza

IL sistema di vigilanza sul farmaco e la normativa per la produzione e la commercializzazione dei prodotti per la salute sono tematiche in continua evoluzione e molto complesse da gestire.

I nostri corsi hanno lo scopo di facilitare la comprensione delle normative e permettervi di restare costantemente aggiornati sugli obblighi regolatori.

Corsi in calendario

Medical Writing in Pharmacovigilance

Update your English writing skills - with many exercises!
dal 07/06/2023 al 12/06/2023
07/06/2023 h. 09:00 - 16:30
12/06/2023 h. 09:00 - 16:30
Dr. Tiziana von Bruchhausen, Boehringer Ingelheim International, Ingelheim, Germany
- Key pharmacovigilance definitions and concepts
- English for technical documents
- Development & Periodic safety update reports: requirements, structure, content
- Introduction to the Risk Management Plan (RMP)
- Practical exercises
- Common pitfalls

Pharmacovigilance Requirements in China - LATAM - EAEU - MENA

5 webcasts in two days: Legal framework, Country-specific requirements and more
dal 12/06/2023 al 13/06/2023
12/06/2023 h. 09:00 - 17:00
13/06/2023 h. 12:00 - 17:00
Ala'a Saleem, Science Forum (SIPS), Amman, JORDAN

Dr. Edelgard Rehak, Dr Edelgard Rehak Consulting, GERMANY

Yanjie Shen, Boehringer Ingelheim, CHINA

Yingxia Zhang, Boehringer Ingelheim, CHINA

Diana González, FIFARMA Latin America Federation of the Pharmaceutical Industry Roche S.A, COLOMBIA

Dr. Tanja Peters, Merck HealthCare KGaA, Darmstadt, GERMANY

Diego A. Salas, FIFARMA Latin America Federation of the Pharmaceutical Industry, COSTA RICA

- Legal framework in selected (emerging) countries
- Similarities and differences compared to EMA regarding ADR collection and reporting
- PSMF, PSURs and RMPs - country-specific requirements
- How to integrate local PV systems into a global system
- Special focus on China, LATAM, EAEU and MENA

Regulatory Lifecycle Management: Variations, Labelling and More

Blended learning programme: e-learning and live online training combined
dal 06/07/2023 al 06/07/2023
09:00 - 17:00
Ingrid Prieschl, Zwiers Regulatory Consultancy B.V., AA Oss, THE NETHERLANDS

Dr. Vicente Tur, ASPHALION S.L., Barcelona, SPAIN
- Classifying and submitting variations
- Fulfilling the required PV duties
- Maintaining and updating product information
- Electronic lifecycle management - new challenges ahead

eSubmission Management in Europe

Current Status of EU digital programmes and implementation in your sector
dal 11/07/2023 al 12/07/2023
11/07/2023 h. 09:00 - 17:00
12/07/2023 h. 09:00 - 17:00
Christine Hirt, MAIN5 GmbH & Co. KGaA, Frankfurt, GERMANY

Aura Jørgensen, NNIT A/S, Copenhagen, DENMARK

Dr Anna Thaidigsmann, EXTEDO, London, UNITED KINGDOM

Frank Dickert, EXTEDO GmbH, Ottobrunn, GERMANY

Sven Harmsen, e-DRA Harmsen - a service provider for electronic drug regulatory affairs, Munich, Germany
- Variation submission - PLM is coming
- IDMP: what you need to know and do
- Regulatory information management
- eCTD around the world
- IT skills for eSubmission managers
- Data integrity and regulatory compliance

EU Regulatory Affairs introductory training course

3-day workshop for beginners in drug regulatory affairs
dal 27/07/2023 al 29/07/2023
27/07/2023 h. 09:00 - 17:00
28/07/2023 h. 09:00 - 17:00
29/07/2023 h. 09:00 - 17:00
Kora Doorduyn-van der Stoep, Medicines Evaluation Board (MEB), Utrecht, THE NETHERLANDS

Dr. Christian M. Moers, Sträter Rechtsanwälte, Bonn

Liane van Houte-Pluimgraaff, College ter Beoordeling van Geneesmiddelen Utrecht, THE NETHERLANDS

Émanuela Negri, Regulatory Affairs, Compliance and Pharmacovigilance Consultant

Nora Rieksta, Regulatory Affairs Specialist, Riga, LATVIA

Dr.ssa Ida Caramazza, Senior Expert Regulatory Affairs, ITALY

Ingrid Prieschl, Zwiers Regulatory Consultancy B.V., AA Oss, THE NETHERLANDS

Karl-Heinz Loebel, PharmaLex GmbH, Mannheim; GERMANY
- Day 1: Marketing Authorisation procedures in Europe: Legal basis, mutual recognition, decentralised and centralised procedure in detail
- Day 2: Marketing Authorisation documents: Data for the dossier, key elements and structure of the SmPC and the package leaflet
- Day 3: Regulatory lifecycle management: Variations, renewals, eCTD and electronic submission

Scientific Medical Writing for Medical Devices

Mastering Key Elements of Effective Scientific Writing
dal 07/09/2023 al 07/09/2023
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

Marketing Authorisation in Latin America

Online seminar with a focus on: Brazil, Mexico, Argentina, Colombia, Chile, Peru
dal 18/09/2023 al 19/09/2023
18/09/2023 h. 09:00 - 17:00
19/09/2023 h. 09:00 - 17:00
Esther Gil López, PAREXEL Consulting, Madrid, ESPANIA

Anita Patel, Parexel International, São Paulo, BRAZIL

- 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!

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

CMC Management in Regulatory Affairs

Quality data for marketing authorisation in Europe
dal 24/10/2023 al 25/10/2023
2 giorni
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 via Zoom.

  • 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
1 giorno
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?