TRAINING - LS ACADEMY...Filling data gaps: methodology, updates and insights in Real World Evidence REAL WORLD DATA AND REAL WORLD EVIDENCE U 4622 [ TRAINING CALENDAR - 2020 ] PAGE

Quality Efficiency Innovation

TRAININGCALENDAR 2020

W W W. L S A C A D E M Y. C O M

WWW.LSACADEMY.COMPAGE 1/6[ TRAINING CALENDAR - 2020 ]

16 April Data Transparency in Clinical Research

The obstacles to data transparency and how to overcome them1 module(1 hour)

9 June From Theory to Practice: Data Integrity

Implementing GxP Data Integrity regulations on everyday practice4 modules(2 hours each)

29 April Disruptions and Protocol Deviations in Clinical

Trials during the COVID-19 Pandemic1 module(1 hour)

7 April1 module(1,5 hour)

Beyond PubMed

Additional approaches and sources for cost-effective

literature monitoring

WEBINAR

WEBINAR

5 May GDPR: Its Impact on Clinical Research Before,

During and After the COVID-19 Pandemic1 module(1 hour)

ONLINE TRAINING

THE COURSE DATES ARE SUBJECT TO CHANGE. FOR MORE DETAILS VISIT THE WEBSITEWEBINAR, ONLINE TRAINING DATES AND MODULE'S LENGHT AVAILABLE ON THE WEBSITE

WEBINAR

CLINICAL RESEARCH AND COMPLIANCE

WEBINAR

2 days

26-27 November Designing and Running a Scientific Symposium

Hungary

BUDAPEST

A comprehensive project-management approach

to deliver an effective symposium

[NEW]

2 days

22-23 October Medical Reading of Scientific ArticlesThe critical evaluation of the scientific paperSpain

BARCELONA

MEDICAL AFFAIRS

Update 15.06.2020

2 days

Writing Articles for Peer-Reviewed Journals in the Health Sciences 2020 TBD



MEDICAL WRITING

MEDICAL DEVICE AND COMPLIANCE

[NEW]Medical Writing: Improve your Writing & Reviewing Skills17 June

Writing, editing & proofreading tips for writers:

a standardised process to review & ensure document quality

3 modules(2 hours each)

ONLINE TRAINING

3 June Medical Devices Registration at an International Level

Regulatory strategy and steps for medical device market access with

an eye on the Americas, the Asian pacific Region and China

[NEW]

25 June Clinical Evaluation Report

How to write a Clinical Evaluation Report from MDR Perspective

25 June 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

[NEW]

3 modules (3 h, 2 h, 1 h)

3 modules (2 h, 2 h, 1 h)


ONLINE TRAINING

ONLINE TRAINING

ONLINE TRAINING

Medical Writing: Improve your Writing & Reviewing Skills14 July

Writing, editing & proofreading tips for writers:

a standardised process to review & ensure document quality


ONLINE TRAINING

Update 15.06.2020


Austria

VIENNA The EU Regulation 2017/745 on Medical Devices

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

2 days

20-21 October

1 day

2020 TBD The Medical Device Clinical Evaluation

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

Austria

VIENNA

1 day

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

8 October


REGUL ATORY AND COMPLIANCE

ONLINE TRAINING Advanced European Regulatory AffairsSeptember

Update on Regulatory Affairs developments in Europe and the impact

on product development and life cycle management

eSubmissions: update on all telematics projects and the

impact on regulatory processes and companies

Get informed about the latest status of all EU projects on electronic

submission, ranging from eCTD, eAF, CESP, xEVMPD, SPOR

and ISO IDMP

20 October

Advanced FDA Regulatory AffairsOctober

In-depth review of US Regulatory Affairs environment

ONLINE TRAINING

ONLINE TRAINING


Update 15.06.2020

PAGE 4/6[ TRAINING CALENDAR - 2020 ] WWW.LSACADEMY.COM

COPENHAGEN Audit Trail Review - Workshop

Theory and Practice

3 November1 day Denmark

[NEW]


ONLINE TRAINING Regulatory and Scientific Pathways for Global ATMPs Development

A broad scientific and regulatory overview of the current status and

challenges facing Advanced Therapy Medicinal Products (ATMPs)

development

November[NEW]

PHARMACOVIGIL ANCE AND COMPLIANCE

2 April

1 module(1,5 hours)

WEBINAR

WEBINAR

How to navigate the different algorithms and approaches used

to evaluate the causality of an adverse event/reaction

“Attributability” in Pharmacovigilance: Still a Hot Topic

How to exploit “machine aided” technologies to increase

the effectiveness of Pharmacovigilance procedures

15 April Natural Language Processing (NLP) and Text Mining:

a Help in Daily Pharmacovigilance Activities1 module(1,5 hours)

8 July2 modules

(1,5 hours each)

The Use of EudraVigilance Data Analysis System (EVDAS)

in the Signal Management System

Quality System in Pharmacovigilance: how to apply Good

Pharmacovigilance Practices (GVPs)

ONLINE TRAINING

The Netherlands

AMSTERDAM1 day

29 September Pharmacovigilance Oversight

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

Update 15.06.2020


1 day Quality System in Pharmacovigilance: how to apply Good Pharmacovigilance Practices (GVPs)

Key Aspects of Compliance in Pharmacovigilance2020 TBD[NEW]


1,5 days

2020 TBD Artificial Intelligence in Pharmacovigilance and

New Technologies. Do We Really Need them?

An overview of what the new digital technologies can do to improve

cost/effectiveness and quality of Pharmacovigilance activities

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 Documents in the Life Cycle of a Medicinal

Product: From Patients to Health Authorities Denmark

COPENHAGEN

2 days

13-14 October

[NEW]

2 days

2020 TBD Inside Real World Evidence

Filling data gaps: methodology, updates and insights in Real World Evidence

REAL W ORLD DATA AND REAL W ORLD EVIDENCE

Update 15.06.2020


Years

22 September MedDev Day

6 October European Epidemiological Forum

3 June German Pharmacovigilance Day*

Pharmacovigilance: Status Quo.

Issues and Challenges in Germany and the EU

New perspectives and future needs of Pharmacovigilance

in the Nordic Countries: embracing the opportunities ahead

CONFERENCES

Germany

BERLIN Patient Partnering in Clinical Development - PPCD

How to Best Integrate Patients into your Strategies

and Operations in Clinical Development – Step III

1,5 days

2-3 March

*THE OFFICIAL LANGUAGE WILL BE GERMAN

28 October Nordic Pharmacovigilance Day

1 day

COPENHAGEN

Denmark

9-10 November European Statistical Forum

Data Science and the Rise of New Analytical Techniques

The Evolution of the Clinical Development Paradigm and Biostatistics

The value of Real-World Evidence in Drug Life Cycle: Promises,

Barriers and Pathways to Success

15 September International Pharmacovigilance Day

A Global Pharmacovigilance Network: Opportunities and Challenges

VIRTUAL

PRAGUE2021 date TBD Eastern Europe Pharmacovigilance Day

Czech Republic

VIRTUAL

VIRTUAL

VIRTUAL

VIRTUAL

AMSTERDAM Benelux Pharmacovigilance Day

The Netherlands Safety and Pharmacovigilance increasing Awareness

of Significant and Essential Needs in Benelux Countries

2021 date TBD

Update 15.06.2020

Via Roma, 20 - 24022 Alzano L.do | Bergamo ITALY

TEL. +39 (0)35. 515684 FAX (+39) 035. 4501262

LIFE SCIENCE ACADEMY

WWW.LSACADEMY.COM

OPPORTUNITIESTRAINING

Your partner

for your

LS Academy can offer in company tailor-made

training courses to meet specific learning needs.

Contact us to design your training course.

[email protected]