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Courses - Archive 2024

13 dicembre 2024
Clinical Research

ICH GCP (R3)

Italiano
10 and 12 December 2024
Animal Health / Pharmacovigilance

Introduction to Veterinary Pharmacovigilance

English
10 December 2024
Clinical Research

Master the New Swiss Clinical Trial Framework and its Interplay with the EU CTR - Similarities and Differences

English
28 November 2024
Pharmacovigilance

The “Global” Qualified Person Responsible for Pharmacovigilance (QPPV) Workshop

English
20 and 25 November 2024
Evidence Generation / Medical Affairs / Medical Writing / Clinical Research

Protocol Writing and Communication of Real World Evidence

English
19 and 21 November 2024
Pharmacovigilance

Mastering Benefit Risk Assessment in Pharmacovigilance

English
20 November 2024
Regulatory

Decoding Electronic Product Information (ePI)

English
06, 13 and 20 November 2024
Medical Affairs / Medical Writing / Clinical Research

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

English
11, 15 e 18 novembre 2024
Clinical Research

Audit to Computer Systems

Italiano
03 December 2024
Animal Health / Pharmacovigilance

Veterinary Pharmacovigilance Quality Management

English
13 e 15 novembre 2024
Clinical Research

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

Italiano
05, 07, 12 e 14 novembre 2024
Pharmacovigilance / Clinical Research

Safety Management e Farmacovigilanza

Italiano
12 e 14 novembre 2024
Medical Device / Regulatory

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

Italiano
12 and 14 November 2024
GMP (Good Manufacturing Practices)

Sterilization Validation

English
26 and 27 November 2024
Medical Device / Medical Affairs / Clinical Research

Medical Reading

English
06, 08 e 13 novembre 2024
Regulatory

Integratori Alimentari - Aspetti Tecnico-Regolatori e Panorama Normativo

Italiano
27 November 2024
Animal Health / Regulatory

Veterinary Marketing Authorisation Variation (MAV) in the EU

English
05 and 07 November 2024
Pharmacovigilance / Medical Affairs / Clinical Research

Beyond PubMed

English
25 November 2024
GMP (Good Manufacturing Practices)

GMP Inspections: How to Be Ready?

English
30 October and 06 November 2024
GMP (Good Manufacturing Practices) / Regulatory

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

English
19 and 21 November 2024
Pharmacovigilance

Pharmacovigilance Quality Management System (QMS)

English
19, 21, 26 and 28 November 2024
GMP (Good Manufacturing Practices)

Computer System Validation (CSV) and Assurance (CSA)

English
29 and 31 October 2024
GMP (Good Manufacturing Practices)

Cleaning Validation

English
29 and 30 October 2024
Medical Device

State of the Art Section for Medical Devices – Unpacking the Tips and Tricks of a Complex Document

English
30 October 2024
Animal Health / Regulatory

Veterinary Marketing Authorisation Application (MAA) in the EU

English
29 October 2024
Medical Device / Medical Affairs / Medical Writing / Clinical Research

Writing Science for Lay Audiences

English
28 and 29 October 2024
Medical Device

Initiating the Development of Artificial Intelligence (AI) Medical Devices

English
21 e 24 ottobre 2024
Medical Affairs / Clinical Research

Terapie Digitali (DTx): a che Punto Siamo?

Italiano
22 and 23 October 2024
Animal Health / Pharmacovigilance

Veterinary Pharmacovigilance System

English
15 e 23 ottobre 2024
Medical Affairs / Regulatory / Clinical Research

Off-Label, Uso Compassionevole e Accesso Precoce (Early Access)

Italiano
23 October 2024
Pharmacovigilance / Medical Writing

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

English
22 October 2024
Medical Device

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

English
04 novembre 2024
GMP (Good Manufacturing Practices)

La Compliance ai Requisiti GMP: Ruolo e Funzioni dell’Assicurazione Qualità

Italiano
05 and 07 November 2024
Regulatory

Marketing Authorization Application in EU, US and UK

English
17 October 2024
Pharmacovigilance / Medical Affairs / Medical Writing / Soft Skill

How to Create Effective Visuals for Better Communicating your Science

English
09 October and 16 October 2024
Pharmacovigilance / Medical Writing

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

English
15 and 16 October 2024
Medical Device

Medical Devices Periodic Safety Update Report (PSUR)

English
17 October 2024
GMP (Good Manufacturing Practices)

Human Error: the True Root Cause of a Deviation?

English
31 ottobre 2024
Medical Device / Pharmacovigilance / Medical Affairs / Medical Writing / Clinical Research

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

Italiano
09 and 10 October 2024
Medical Affairs / Medical Writing / Clinical Research

Medical Writing Course: Improve your Writing & Reviewing Skills

English
23 and 24 October 2024
Medical Writing / Clinical Research

Clinical Study Reports – a 360° Perspective

English
22 e 29 ottobre 2024
Regulatory

Terapie Geniche e Terapie Cellulari

Italiano
01 e 03 ottobre 2024
Regulatory

Cosmetici - Aspetti Tecnico-Regolatori e Panorama Normativo

Italiano
21 and 28 October 2024
GMP (Good Manufacturing Practices)

Biologics and Biosimilars Manufacturing

English
02 October 2024
Regulatory

Electronic Submissions and Data Management in Regulatory Affairs

English
02 October 2024
Pharmacovigilance / Medical Writing

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

English
09 ottobre 2024
Regulatory

Integratori Alimentari ed Advertising

Italiano
15 and 17 October 2024
Regulatory

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

English
15 October 2024
GMP (Good Manufacturing Practices)

Introduction to Aseptic Process Simulation (APS)

English
26 e 27 settembre 2024
Pharmacovigilance / GMP (Good Manufacturing Practices) / Clinical Research

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

Italiano
25 e 26 settembre 2024
Medical Device

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

Italiano
23 and 26 September 2024
Medical Device / Pharmacovigilance / Market Access / Medical Affairs / Medical Writing / Clinical Research

Searching the Medical Literature

English
25 September 2024
Pharmacovigilance / Medical Writing

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

English
10 and 11 October 2024
Medical Device / Regulatory

US FDA 101 - Fundamentals of Pre-market Submissions to CDRH

English
23 e 24 settembre 2024
Medical Device / Regulatory

La Biocompatibilità e la Caratterizzazione Chimica: Dispositivi Medici Sicuri

Italiano
STEP 2 : 10 and 17 October 2024
Evidence Generation / Medical Affairs / Clinical Research

A Systematic Approach to Real World Evidence (RWE) Generation in Life Sciences - A 2 Step Intensive Course

English
24 e 26 settembre 2024
Medical Device / Pharmacovigilance / Medical Affairs / Medical Writing / Clinical Research

La Ricerca della Letteratura Scientifica: dal Quesito ai Risultati

Italiano
16, 19 and 23 September 2024
Pharmacovigilance / Regulatory

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

English
27 settembre 2024
Medical Affairs / Regulatory

Codice Deontologico di Farmindustria e le Linee Guida per la Certificazione delle Attività Scientifiche: come applicarle in azienda

Italiano
08 e 10 ottobre 2024
Regulatory

Gestione della Proprietà Industriale - Il Brevetto per Tutelare le Invenzioni

Italiano
20 settembre 2024
GMP (Good Manufacturing Practices)

ICH Q9 Quality Risk Management

Italiano
19 e 20 settembre 2024
IVDs (In-Vitro Diagnostics) / Clinical Research

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

Italiano
18 e 19 settembre 2024
GMP (Good Manufacturing Practices)

EU GMP Annex 15 - La Qualifica e la Convalida nell'Industria Farmaceutica

Italiano
17, 18 and 19 September 2024
Medical Writing

Tips and Tricks to Improve your Technical/Scientific Writing

English
18 September 2024
Pharmacovigilance / Medical Writing

Pharmacovigilance Documents - Basic Concepts and Definitions for Pharmacovigilance Writing

English
01 and 02 October 2024
GMP (Good Manufacturing Practices)

Process Validation

English
24, 26 settembre e 01 ottobre 2024
Market Access / Medical Affairs / Regulatory

Patient Support Program (PSP) e Patient Solution: Compiere una Scelta Strategica a Supporto del Paziente

Italiano
16 September 2024
GMP (Good Manufacturing Practices)

Quality by Design

English
17 and 18 September 2024
Pharmacovigilance

Introduction to Pharmacovigilance

English
17 September 2024
Animal Health / Regulatory

Good Distribution Practices (GDP) for Veterinary Medicinal Products

English
16 and 17 July 2024
Medical Device / Regulatory / Clinical Research

Good Distribution Practices of Medical Devices

English
25 e 27 giugno, 2 e 4 luglio 2024
Clinical Research

Selezione e Convalida di Una Soluzione Cloud in Ambito GxP

Italiano
02 July 2024
GMP (Good Manufacturing Practices)

Statistical Process Control for Pharmaceutical Manufacturing

English
28 giugno 2024
Clinical Research

Qualifica dei Vendor nella Ricerca Clinica - Approfondimenti

Italiano
18, 24 and 27 June 2024
Clinical Research / Statistics and Data Management

A Practical Guide to Innovative Trial Design

English
26 giugno 2024
Regulatory

Integratori Alimentari e Advertising: Applichiamo la Teoria alla Pratica

Italiano
14 and 21 June 2024
Pharmacovigilance

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

English
18 and 20 June 2024
Regulatory

Fundamentals of European Cosmetics Regulatory Affairs

English
18 and 20 June 2024
Pharmacovigilance

Pharmacovigilance System: Audit & Inspection Readiness

English
19 and 20 June 2024
Medical Device / Regulatory

Combination Products under the EU Medical Devices Regulation (MDR)

English
10 e 17 giugno 2024
Medical Affairs

Hospital Meeting: come Pianificare e Condurre una Riunione di Successo

Italiano
10, 14 e 17 giugno 2024
Regulatory / Clinical Research

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

Italiano
02 and 03 July 2024
Medical Device

Labelling Requirements for Medical Devices

English
25 and 26 June 2024
Animal Health / Pharmacovigilance

Reporting Requirements in Veterinary Pharmacovigilance

English
06, 07, 12 e 14 giugno 2024
Pharmacovigilance

Il Sistema di Qualità Applicato alla Farmacovigilanza

Italiano
04, 06 e 11 giugno 2024
Pharmacovigilance

Signal Detection e Signal Management

Italiano
12 e 13 giugno 2024
Medical Affairs

Il Patient Support Program (PSP) e la Transizione Digitale: Opportunità e Rischi

Italiano
05 e 07 giugno 2024
Pharmacovigilance

La Gestione del Case Processing in Farmacovigilanza

Italiano
04 e 06 giugno 2024
Clinical Research

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

Italiano
28 e 30 maggio 2024
Medical Affairs

Il Responsabile del Servizio Scientifico

Italiano
21, 24 and 28 May 2024
Pharmacovigilance / Regulatory

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

English
27 May 2024
Soft Skill

Oral Presentations

English
11 giugno 2024
GMP (Good Manufacturing Practices)

Le Good Calibration Practices (GCalP) negli Impianti Automatici di Produzione

Italiano
23 e 24 maggio 2024
Medical Affairs / Soft Skill

La Gestione dell’Advisory Board nei Progetti Life Science

Italiano
22 maggio 2024
Pharmacovigilance / Market Access / Medical Affairs / Regulatory

Patient Support Program (PSP) e Compliance: quali Normative Considerare?

Italiano
22 maggio 2024
Regulatory

Etichettatura degli Integratori Alimentari - Applichiamo la Normativa ad Esempi Reali

Italiano
21 and 22 May 2024
Pharmacovigilance

Pharmacovigilance Agreements

English
14, 16 e 21 maggio 2024
Medical Affairs

Patient Advocacy ed Engagement nell’Azienda Farmaceutica

Italiano
04 June 2024
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

English
05 e 06 giugno 2024
Soft Skill

Comunicare con l'Intelligenza Relazionale

Italiano
16 and 17 May 2024
Medical Device / IVDs (In-Vitro Diagnostics) / Regulatory

Person Responsible for Regulatory Compliance (PRRC) - An MDR/IVDR Requirement

English
13, 15 and 16 May 2024
Medical Device

How to Write a Clinical Evaluation Plan and Report

English
07 e 09 maggio 2024
Regulatory

La Pubblicità del Farmaco

Italiano
08 maggio 2024
Medical Affairs

Progettare e Comunicare in Medical Affairs

Italiano
15 e 16 maggio 2024
IVDs (In-Vitro Diagnostics)

La Sorveglianza Post-Market dei Dispositivi Diagnostici in Vitro

Italiano
22 May 2024
Soft Skill

Beyond Slide Decks

English
29 April 2024
Medical Device

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

English
23 April 2024
Medical Device

Select the Ideal PMCF Strategy for a Medical Device

English
23 aprile 2024
Medical Affairs

Progettare un Patient Support Program (PSP): Configurazione del Processo e Strumenti

Italiano
09 e 10 maggio 2024
GMP (Good Manufacturing Practices)

Agile Project Management: Gestire l’Innovazione nel Contesto della Produzione Farmaceutica

Italiano
18 April 2024
Medical Device / IVDs (In-Vitro Diagnostics) / Medical Affairs / Regulatory

Advertisement and Promotion Claims for Medical Devices

English
16 e 18 aprile 2024
Clinical Research

Normativa della Ricerca Clinica tra Presente e Futuro

Italiano
09 e 11 aprile 2024
Medical Affairs

Il Responsabile del Servizio Scientifico

Italiano
10 and 11 April 2024
Medical Affairs / Medical Writing / Clinical Research

Medical Writing Course: Improve your Writing & Reviewing Skills

English
10 aprile 2024
Medical Affairs / Regulatory / Clinical Research

I Radiofarmaci

Italiano
03 e 05 aprile 2024
GMP (Good Manufacturing Practices)

Le Sfide della Produzione di un Investigational Medicinal Product (IMP)

Italiano
03, 04 and 05 April 2024
Medical Affairs / Medical Writing

Clinical Study Protocols – Structure & Content

English
26 e 27 marzo 2024
GMP (Good Manufacturing Practices)

Annex 1 e Contamination Control Strategy

Italiano
26 marzo 2024
Medical Affairs / Regulatory / Clinical Research

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

Italiano
20, 21 and 25 March 2024
Medical Device

How to Write a Clinical Evaluation Plan and Report

English
14, 19 e 21 marzo 2024
Medical Affairs / Clinical Research / Statistics and Data Management

La Statistica Medica per Non Statistici

Italiano
20 March 2024
Pharmacovigilance

“Attributability” in Pharmacovigilance: Still a Hot Topic

English
13 and 15 March 2024
Medical Affairs

The Next Generation of Medical Affairs: ChatGPT and Large Language Models (LLMs)

English
12 and 13 March 2024
Medical Device

Medical Devices Periodic Safety Update Report (PSUR)

English
06 and 07 March 2024
Medical Device / Regulatory

Clinical Evaluation for Medical Devices

English
29 February and 01 March 2024
Medical Device / Regulatory

Labelling Requirements for Medical Devices

English
TBD
Market Access

Healthcare Modeling: Interventi per Migliorare Efficacia ed Efficienza delle Cure

Italiano
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