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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
WWW.LSACADEMY.COMPAGE 2/6[ TRAINING CALENDAR - 2020 ]
THE COURSE DATES ARE SUBJECT TO CHANGE. FOR MORE DETAILS VISIT THE WEBSITEWEBINAR, ONLINE TRAINING DATES AND MODULE'S LENGHT AVAILABLE ON THE WEBSITE
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)
3 modules(2 hours each)
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
3 modules(2 hours each)
ONLINE TRAINING
Update 15.06.2020
WWW.LSACADEMY.COMPAGE 3/6[ TRAINING CALENDAR - 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
THE COURSE DATES ARE SUBJECT TO CHANGE. FOR MORE DETAILS VISIT THE WEBSITEWEBINAR, ONLINE TRAINING DATES AND MODULE'S LENGHT AVAILABLE ON THE WEBSITE
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
3 modules(3 hours each)
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]
THE COURSE DATES ARE SUBJECT TO CHANGE. FOR MORE DETAILS VISIT THE WEBSITEWEBINAR, ONLINE TRAINING DATES AND MODULE'S LENGHT AVAILABLE ON THE WEBSITE
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
PAGE 5/6[ TRAINING CALENDAR - 2020 ] WWW.LSACADEMY.COM
1 day Quality System in Pharmacovigilance: how to apply Good Pharmacovigilance Practices (GVPs)
Key Aspects of Compliance in Pharmacovigilance2020 TBD[NEW]
THE COURSE DATES ARE SUBJECT TO CHANGE. FOR MORE DETAILS VISIT THE WEBSITEWEBINAR, ONLINE TRAINING DATES AND MODULE'S LENGHT AVAILABLE ON THE WEBSITE
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
PAGE 6/6[ TRAINING CALENDAR - 2020 ] WWW.LSACADEMY.COM
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.
training@lsacademy.com
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