Discover all the

Courses

for Pharmaceutical and Medical Devices Professionals

  • Selected highly recognised teachers
  • Personalised needs Analysis
  • Updated programs and topics
  • A limited number of participants
  • Evaluation of expectations achievement

Regulation and Compliance

The world of Regulations and Compliance has become increasingly demanding and rigorous. Being informed and aware of the Regulations to be followed is essential in the medical field. Our courses on Regulations and Compliance help professionals involved in the healthcare field increase their regulatory knowledge and to ensure Compliance in their daily work. The Regulation and Compliance courses are designed as interactive workshops, which include lectures, discussions and exercises.

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Courses found: 21
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General Data Protection Regulation (GDPR), Clinical Trials and Local Legislation
10 March 2020
Milan

General Data Protection Regulation (GDPR), Clinical Trials and Local Legislation

A training for understanding the impact of GDPR in clinical trials both at local and international level

Device Drug and Drug Device Combination Products in the EU under the Medical Devices Regulation (MDR)
17 March 2020
Vienna

Device Drug and Drug Device Combination Products in the EU under the Medical Devices Regulation (MDR)

A targeted training to understand the regulatory pathway of device drug and drug device combinations (DDCP) in the European Union
Latest updates from the MDR 2017/745 and EMA guidance

From Theory to Practice: Data Integrity
24 - 25 March 2020
Milan

From Theory to Practice: Data Integrity

Implementing GxP Data Integrity regulations on everyday practice

Labelling Requirements for Medical Devices under the Medical Devices Regulation 2017/745 (MDR)
02 April 2020
Vienna

Labelling Requirements for Medical Devices under the Medical Devices Regulation 2017/745 (MDR)

A one-day training to understand medical device Labelling requirements under the MDR 2017/745

Audits and Auditors 4.0 Working According to GxP
07-08 April 2020
Milan

Audits and Auditors 4.0 Working According to GxP

Innovative Approaches to Audit and Challenges for Auditors Working on New Requirements and Emerging Technologies

Data Transparency: Its Impact on Clinical Trials
20 - 21 April 2020
Berlin

Data Transparency: Its Impact on Clinical Trials

Effectively facing with the new environment of clinical studies

Pharmacovigilance Documents in the Life Cycle of a Medicinal Product: From Patients to Health Authorities
21-22 April 2020
Rome

Pharmacovigilance Documents in the Life Cycle of a Medicinal Product: From Patients to Health Authorities

Development Safety Update Report (DSUR), Risk Management Plan (RMP), Periodic Safety Update Report (PSUR) / Periodic Benefit-Risk Evaluation Report (PBRER), and Addendum to the Clinical Overview 

Pharmacovigilance Oversight
21 April 2020
Amsterdam

Pharmacovigilance Oversight

How to guarantee quality and to manage pharmacovigilance audits and inspections succesfully in PV oversight activities

The Medical Device Clinical Evaluation
22 April 2020
Copenhagen

The Medical Device Clinical Evaluation

Understanding the clinical evaluation requirements for the MedTech industry
Latest news from MDR 2017/745 and ISO 14155!

FDA Medical Devices Registration
29 April 2020
Milan

FDA Medical Devices Registration

Different submission types and how to prepare a 510K

New EU Medical Devices Regulation 2017/745 Training Course: Get Ready to Implement the MDR!
06 - 07 May 2020
Berlin

New EU Medical Devices Regulation 2017/745 Training Course: Get Ready to Implement the MDR!

Understanding the Medical Devices Regulation and its impact on Industry
Latest updates before the MDR 2017/745 date of application

Advanced European Regulatory Affairs
07 - 08 May 2020
Amsterdam

Advanced European Regulatory Affairs

Update on Regulatory Affairs developments in Europe and the impact on product development and life cycle management

Real-World Data and Real-World Evidence
12 - 13 May 2020
Milan

Real-World Data and Real-World Evidence

An intensive Lab Workshop to learn the main concepts behind Real-World Evidence and Observational Research and to design innovative studies that generate evidence

Quality, Compliance and Audit in GVP
13 - 14 May 2020
Milan

Quality, Compliance
and Audit in GVP

How to apply Good Pharmacovigilance Practices (GVPs) to Quality Management and Pharmacovigilance Auditing

Medical Writing: Improve your Writing & Reviewing Skills
26 May 2020
Copenhagen

Medical Writing: Improve your Writing & Reviewing Skills

Writing, editing & proofreading tips for medical writers: a standardised process to make your message effective, review & ensure document quality

Audit Trail Review – Workshop
16 June 2020
Milan

Audit Trail Review – Workshop

From regulations to practice

Implementation of the 2017/745 MDR by Notified Bodies: Weaknesses of the Technical Documentation
25 June 2020
Milan

Implementation of the 2017/745 MDR by Notified Bodies: Weaknesses of the Technical Documentation

Insights of the MDR and most relevant issues identified by Notified Bodies during the evaluation process 

From Theory to Practice: Data Integrity
29 - 30 September 2020
Madrid

From Theory to Practice: Data Integrity

Implementing GxP Data Integrity regulations on everyday practice

Pharmacovigilance Documents in the Life Cycle of a Medicinal Product: From Patients to Health Authorities
13-14 Oct 2020
Copenhagen

Pharmacovigilance Documents in the Life Cycle of a Medicinal Product: From Patients to Health Authorities

Development Safety Update Report (DSUR), Risk Management Plan (RMP), Periodic Safety Update Report (PSUR) / Periodic Benefit-Risk Evaluation Report (PBRER), and Addendum to the Clinical Overview 

The EU Medical Devices Regulation 2017/745
20 - 21 October 2020
Vienna

The EU Medical Devices Regulation 2017/745

Understanding the Medical Devices Regulation and its impact on Industry
Latest updates after the MDR 2017/745 date of application

Audit Trail Review – Workshop
3 November 2020
Copenhagen

Audit Trail Review – Workshop

From regulations to practice

Participants' Feedbacks

Good size of number of partcipants;  interesting agenda with appropriate time allocated for presentations and question and answers 

Only positive: very expert presenters in this field, very good discussion at high level

In each topic there was some relevance to my daily work

Perfect organisation, great speakers, relevant topics

Perfect opportunity to have "hot topics" to discuss outside the"own environnment". Opportunity to have several topics discussing in just one day

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Trainings
The fee includes: tuition, teaching materials, lunches and coffee breaks, organizational office assistance, attendance certificate. Early Bird discount not applicable to Freelance – Academy – Public Administration fee.
The course will proceed with a minimum of 8 participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
For further information please contact:  e-mail: training@LSAcademy.com  telephone: +39 (0)35.515684

Conferences
The fee includes: seat at the conference, copy of presentations of Speakers who allow the distribution, informative literature for the day, networking lunch, coffee break, organisational office assistance, certificate of attendance. For further information please contact:  e-mail: events@LSAcademy.com  telephone: +39 (0)35.515684

Common Terms & Conditions

Terms of payment
Payment should be made online (by credit card) or by bank transfer, at the time of registration (only for Italian companies: + 22% VAT) to EasyB s.r.l by bank transfer or by credit card. Bank transfer payable to:

EasyB S.r.l.
Via Roma, 20 – 24022 Alzano Lombardo (Bergamo)
VAT: IT03633040161
BANCO BPM – Filiale di Carobbio degli Angeli
IBAN: IT81 F 05034 53960 000000003450
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Confirmation of event admission will be given on receipt of payment. Invoice will be sent following receipt of payment. EasyB reserves the right to refuse late registrations or additional registrations above the maximum accepted number of participants or registrations of roles that are not included in the target of the event.

Cancellation
Please note that refunds (70% refund of the registration fee) will only be given if cancellation is received at least one week before the event date. Cancellations will only be valid if made in writing. Transfer of registrations (or name changes) are allowed and should be made in writing within 7 days prior to the event. EasyB reserves the right to postpone or cancel an event, to change the location of an event or to alter the advertised speakers for an event. EasyB is not responsible for any loss or damage as a result of substitution, alteration, postponement or cancellation of an event due to causes beyond its control including without limitation, acts of God, natural disasters, sabotage, accident, trade of industrial disputes, terrorism, or hostilities.

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