Events Archive - LS Academy

30 November and 04 December 2023

Evidence Generation / Medical Affairs / Clinical Research

Advanced Training: Designing a Pre- or Post-Marketing Observational Study

21, 23, 28 e 30 novembre 2023

Pharmacovigilance / Clinical Research

Safety Management e Farmacovigilanza

28 November 2023

Medical Device

From Good to Excellence: State of the Art Section for Medical Devices Inside-Out

24 November 2023

Pharmacovigilance

Veterinary Pharmacovigilance: Suspected Adverse Event and Signal Management

21 e 23 novembre 2023

Regulatory

Integratori Alimentari - Aspetti Tecnico-Regolatori e Panorama Normativo

21 e 22 novembre 2023

Medical Device / Regulatory

Dispositivi Medici Sicuri – La Biocompatibilità e la Caratterizzazione Chimica

22 November 2023

Medical Writing / Soft Skill

How to Create Effect Visuals for Better Communicating your Science

08, 15 and 22 November 2023

Medical Affairs / Clinical Research / Statistics and Data Management

All You Need to Know to Understand Statistic if You are not a Statistician

04 e 05 dicembre 2023

Medical Device / Regulatory

Il Processo di Gestione dei Rischi applicato ai Dispositivi Medici

10, 13, 17 e 20 novembre 2023

Pharmacovigilance / GMP (Good Manufacturing Practices) / Regulatory / Clinical Research

Integrare la Cyber Security nei Sistemi GxP

14 e 16 novembre 2023

Medical Device / Regulatory

La Vigilanza Post Market per i Dispositivi Medici secondo MDR e FDA

15 and 16 November 2023

Medical Device

Initiating the Development of Artificial Intelligence (AI) Medical Devices

13 e 14 novembre 2023

Clinical Research

Condurre uno Studio Clinico Adempiendo alla Normativa GDPR: un Ponte fra Good Clinical Practices (GCP) e General Data Protection Regulation (GDPR)

13 novembre 2023

Regulatory

Navigare le Novità: le Ultime Revisioni al Codice Deontologico di Farmindustria e le Linee Guida per la Certificazione delle Attività Scientifiche

09 e 10 novembre 2023

Pharmacovigilance

La Gestione del Case Processing in Farmacovigilanza

09 November 2023

Medical Device / IVDs (In-Vitro Diagnostics) / Medical Affairs / Regulatory

Advertisement and Promotion Claims for Medical Devices

06 and 08 November 2023

Evidence Generation / Market Access / Medical Affairs / Clinical Research

Patient Registries as a Source of Real-World Evidence not only for Pharmaceuticals but also for Medical Devices

22, 24 and 27 November 2023

Medical Affairs

Patient Advocacy and Engagement in Pharmaceutical Companies

20 e 23 novembre 2023

Market Access

Il Market Access a Supporto del Time to Market

25 e 27 ottobre 2023

Regulatory

Off-Label, Uso Compassionevole ed Expanded Access Program. Come Orientarsi tra Normative, Studi, Ricerca e Realtà Clinica

24 and 26 October 2023

GMP (Good Manufacturing Practices) / Regulatory

Advanced Therapy Medicinal Product (ATMP) Roadmap from Classification to Regulation and Manufacturing

25 and 26 October 2023

Medical Writing / Clinical Research

Clinical Study Reports – a 360° Perspective

26 ottobre 2023

Medical Device / Pharmacovigilance / Market Access / Medical Affairs / Medical Writing / Clinical Research

La Ricerca della Letteratura Scientifica: come Sfruttare le Risorse Gratuite in Rete

25 and 26 October 2023

Medical Device

What You Need to Know about Medical Device Software and Never Dared to Ask

17, 19 and 24 October 2023

Medical Device / Evidence Generation / Medical Affairs / Clinical Research

Generating Real World Evidence (RWE) with Observational Methods

24 October 2023

Medical Device / Medical Affairs / Medical Writing / Clinical Research

Writing Science for Lay Audiences

16 e 21 novembre 2023

Regulatory

Technology Transfer e Proprietà Intellettuale

07 e 08 novembre 2023

Medical Device

Medical Device Software

07, 09 and 14 November 2023

Pharmacovigilance

Benefit Risk Assessment in Pharmacovigilance

07 November 2023

Medical Device / Medical Affairs / Medical Writing / Clinical Research

How to Become a Successfully Published Author - Practical steps to make the publication process as smooth and as successful as possible

03, 10, 17 e 20 ottobre 2023

Pharmacovigilance

Qualità in Farmacovigilanza

17 and 19 October 2023

Medical Device

Medical Devices Periodic Safety Update Report (PSUR)

17 and 19 October 2023

Regulatory

The Basics of Regulatory Affairs for Cosmetic Products in US and Canada

13 November 2023

Clinical Research / Statistics and Data Management

Design and Analysis of Clinical Trials in the Era of Precision Medicine

18 October 2023

Pharmacovigilance / Medical Writing

Pharmacovigilance Documents – Focus on Addendum to the Clinical Overview (AddCO) and Referrals

11 e 13 ottobre 2023

Regulatory

Cosmetici - Aspetti Tecnico-Regolatori e Panorama Normativo

10 and 11 October 2023

Medical Affairs / Medical Writing / Clinical Research

Medical Writing Course: Improve your Writing & Reviewing Skills

28 September and 11 October 2023

Pharmacovigilance / Medical Writing

Pharmacovigilance Documents – Focus on the Periodic Safety Update Report (PSUR)

10 ottobre 2023

Medical Affairs / Regulatory / Clinical Research

Terapie Geniche e Terapie Cellulari

23 and 25 October 2023

Medical Device / Pharmacovigilance / Market Access / Medical Affairs / Medical Writing / Clinical Research

Beyond PubMed

04, 05 and 06 October 2023

Medical Affairs / Medical Writing

Clinical Study Protocols – Structure & Content

05 October 2023

Regulatory

Electronic Submissions and Data Management in Regulatory Affairs

20 e 27 ottobre 2023

GMP (Good Manufacturing Practices)

Audit GMP: la Qualifica della Supply Chain

02 e 04 ottobre 2023

Regulatory

Gestione della Proprietà Industriale - Il Brevetto a Tutela delle Invenzioni

19 and 20 October 2023

Soft Skill

What you Need to Know about Management and never Dared to Ask

27 e 29 settembre 2023

Pharmacovigilance / GMP (Good Manufacturing Practices) / Clinical Research

Buone Pratiche per la Gestione dei Documenti Cartacei e dei Dati Elettronici in Ambito GxP

27 e 29 settembre 2023

Medical Device / Pharmacovigilance / Market Access / Medical Affairs / Medical Writing / Clinical Research

La Ricerca della Letteratura Scientifica: dal Quesito ai Risultati

11, 18 e 25 ottobre 2023

Medical Device / Market Access

Il Market Access per i Dispositivi Medici

12 e 13 ottobre 2023

Medical Device / Regulatory

L’Ingegneria dell’Usabilità applicata ai Dispositivi Medici

26 September 2023

Pharmacovigilance / Medical Writing

Pharmacovigilance Documents - Focus on the Risk Management Plan (RMP)

25 and 26 September 2023

Medical Device / Pharmacovigilance / Market Access / Medical Affairs / Medical Writing / Clinical Research

Searching the Medical Literature

25 September 2023

Medical Device

From Good to Excellent: The Summary of Safety and Clinical Performance (SSCP)

19, 20 and 21 September 2023

Medical Writing

Tips and Tricks to Improve your Technical/Scientific Writing

19 e 21 settembre 2023

Medical Device / Regulatory / Clinical Research

ISO 14155/2020 - Come Svolgere uno Studio Clinico con Dispositivi Medici

20 September 2023

Pharmacovigilance / Medical Writing

Pharmacovigilance Documents - Focus on Signal Management and Development Safety Update Reports (DSUR)

12, 14 e 19 settembre 2023

Pharmacovigilance

Signal Detection e Signal Management

04 ottobre 2023

Medical Device / Evidence Generation / Medical Affairs

Come Produrre Dati Non Clinici e Comunicare Contenuti Scientifici in Poco Tempo? Elementare, Watson!

26, 27 e 28 settembre 2023

Soft Skill

Comunicare con l'Intelligenza Relazionale - La Flessibilità nelle Relazioni per Comunicare, Guidare e Motivare Colleghi e Interlocutori, in Presenza e da Remoto

13 September 2023

Pharmacovigilance / Medical Writing

Pharmacovigilance Documents - Basic Concepts and Definitions for Pharmacovigilance Writing

13 settembre 2023

Regulatory

Integratori Alimentari a Base di Botanicals

03 e 05 ottobre 2023

Evidence Generation

Corso avanzato per la Progettazione di uno Studio Osservazionale Pre o Post Marketing

26 and 28 September 2023

Evidence Generation / Market Access / Medical Affairs / Clinical Research

How Are You? – Asking the Patients - Patient-Reported Outcomes (PRO) with Focus on Measuring Quality of Life (QoL)

18 e 20 settembre 2023

Medical Device / Regulatory

La Valutazione Clinica di un Dispositivo Medico

19 settembre 2023

GMP (Good Manufacturing Practices) / Soft Skill

Lean Six Sigma nel Mondo Farmaceutico - Strumenti “LEAN” per l’Ottimizzazione dei Processi in Ambito Good Manufacturing Practices (GMP)

05 luglio 2023

Regulatory

Integratori Alimentari ed Advertising - Caratteristiche di una Corretta Comunicazione Commerciale e Vincoli Normativi

28 and 30 June 2023

Pharmacovigilance

Pharmacovigilance System: Audit & Inspection Readiness

07, 14, 21 e 28 giugno 2023

Pharmacovigilance

Qualità in Farmacovigilanza

22, 23 and 27 June 2023

Pharmacovigilance / Regulatory

Pharmacovigilance and Safety in Clinical Trials under the Clinical Trial Regulation (EU) No 536/2014

21 and 22 June 2023

Medical Device / Regulatory

Combination Products under the EU Medical Devices Regulation (MDR)

20 and 22 June 2023

Regulatory

Fundamentals of European Cosmetics Regulatory Affairs

21 giugno 2023

Medical Affairs / Regulatory / Clinical Research

I Trasferimenti dei Dati Personali extra SEE

13, 15 e 20 giugno 2023

Medical Affairs

Patient Support Program (PSP) - Dalla Strategia al Management

12 e 19 giugno 2023

Medical Affairs

Hospital Meeting: come Pianificare e Condurre una Riunione di Successo

28 June 2023

Soft Skill

Great Topic – Shame About the Slides!

04, 06 e 11 luglio 2023

Market Access

Regolamento Europeo di Health Technology Assessment (EU-HTA)

20, 23 e 27 giugno 2023

Clinical Research / Soft Skill

La Ricerca Clinica e l’Efficacia della Comunicazione nel Lavoro di Gruppo

16 giugno 2023

GMP (Good Manufacturing Practices)

ICH Q9 Quality Risk Management

14 and 15 June 2023

Medical Device / Regulatory

The EU Regulation 2017/745 on Medical Devices

14 giugno 2023

GMP (Good Manufacturing Practices) / Regulatory / Clinical Research

GAMP 5 A Risk-Based Approach to Compliant GxP Computerized Systems- Release 2

12 and 13 June 2023

Medical Device

Medical Devices Periodic Safety Update Report (PSUR)

16, 18, 23 maggio e 01 giugno 2023

Clinical Research

Selezione e Convalida di Una Soluzione Cloud in Ambito GxP

24, 26 and 31 May 2023

Pharmacovigilance

The Pharmacovigilance System Master File (PSMF): from GVPs to Inspections

30 May 2023

Soft Skill

Oral Presentations

12, 13, 19 e 20 giugno 2023

Soft Skill

Selling with Papers: la Comunicazione dei Risultati Clinici

12 and 14 June 2023

Medical Affairs / Medical Writing / Clinical Research

Medical Writing Course: Improve your Writing & Reviewing Skills

24 and 26 May 2023

Medical Device / Medical Affairs / Clinical Research

Medical Reading

25 e 26 maggio 2023

Medical Affairs / Soft Skill

La Gestione dell’Advisory Board nei Progetti Life Science

09, 12 e 16 giugno 2023

Regulatory / Clinical Research

Computer System Validation - GxP Process Owner and Quality Assurance: In or Out?

16, 18 e 23 maggio 2023

Evidence Generation

Generare Real World Evidence (RWE) con Metodi Osservazionali

23 maggio 2023

Clinical Research

Qualifica dei Vendor nella Ricerca Clinica - Approfondimenti

17, 19 e 22 maggio 2023

Medical Affairs

Patient Advocacy ed Engagement nell’Azienda Farmaceutica

18 and 19 May 2023

Medical Device / IVDs (In-Vitro Diagnostics) / Regulatory

New MDR/IVDR Requirement: the ‘Person Responsible for Regulatory Compliance’ (PRRC)

17 e 18 maggio 2023

IVDs (In-Vitro Diagnostics)

La Sorveglianza Post-Market dei Dispositivi Diagnostici in Vitro

04, 11 and 12 May 2023

Pharmacovigilance / Regulatory

Pharmacovigilance and Safety in Clinical Trials under the Clinical Trial Regulation (EU) No 536/2014

09 e 11 maggio 2023

Regulatory

La Pubblicità del Farmaco

05 May 2023

Medical Device

The Summary of Safety and Clinical Performance (SSCP)

03 e 04 maggio 2023

Medical Device / Regulatory

La Registrazione dei Dispositivi Medici presso FDA

26 and 28 April 2023

Medical Device

Knowing your Post-Market Clinical Follow-up (PMCF)

18 e 20 aprile 2023

Clinical Research

Normativa della Ricerca Clinica tra Presente e Futuro

18 e 19 aprile 2023

IVDs (In-Vitro Diagnostics) / Clinical Research

La Conduzione di uno Studio Clinico con un Dispositivo Medico-Diagnostico in Vitro

12 April 2023

Pharmacovigilance

Pharmacovigilance Agreements

04 e 06 aprile 2023

Medical Affairs

Il Responsabile del Servizio Scientifico

06 April 2023

Medical Device / IVDs (In-Vitro Diagnostics) / Medical Affairs / Regulatory

Advertisement and Promotion Claims for Medical Devices

20 and 21 April 2023

Medical Device / IVDs (In-Vitro Diagnostics) / Regulatory

How to Globally Register a Medical Device

28 marzo 2023

Medical Affairs / Regulatory / Clinical Research

Il Consenso quale Base Giuridica per il Trattamento Dati nella Ricerca Clinico-Scientifica

21, 23 e 28 marzo 2023

Medical Affairs / Clinical Research / Statistics and Data Management

La Statistica Medica per Non Statistici

27 marzo 2023

Medical Affairs / Regulatory / Clinical Research

I Radiofarmaci

22 and 23 March 2023

Medical Device

Medical Devices Periodic Safety Update Report (PSUR)

22 March 2023

Pharmacovigilance

“Attributability” in Pharmacovigilance: Still a Hot Topic

14, 16 and 21 March 2023

Medical Device

How to Write a Clinical Evaluation Plan and Report

09 e 20 marzo 2023

GMP (Good Manufacturing Practices)

Annex 1 e la Contamination Control Strategy

28, 29, 31 marzo 2023

Medical Affairs / Medical Writing / Regulatory

Struttura e Contenuti del Protocollo di uno Studio Clinico

30 marzo e 04 aprile 2023

Evidence Generation / Market Access / Medical Affairs

Utilizzo dei Dati Derivanti dai PSP: Confini e Opportunità

28 febbraio e 02 marzo 2023

Clinical Research

General Data Protection Regulation (GDPR), Ricerca Scientifica e Norme Locali

01 and 02 March 2023

Medical Affairs / Medical Writing / Clinical Research

Medical Writing Course: Improve your Writing & Reviewing Skills

01 March 2023

Regulatory / Clinical Research

Clinical Trials Information System (CTIS) Interactive Demo

28 February and 01 March 2023

Medical Device / Regulatory

Clinical Evaluation for Medical Devices

18 ottobre 2023

Evidence Generation / Clinical Research