Видео 28
Просмотров 6 655

Unlocking Success: The FSP Advantage in Clinical Research

52:17

Regulatory Outsourcing in the CEE Region

46:14

Benefits of Integrating Pharmacovigilance & Medical Information

1:00:58

Oncology trials in a shifting economical and geopolitical landscape

57:16

Setting up a pharmacovigilance system in Europe: Where to start? What to consider?

59:09

How to avoid delays in your early phase oncology trial?

51:37

Breaking silos across Medical Information & Pharmacovigilance

Discover solutions for effective PV & MI data management, including handling Adverse Events, Product Quality Complaints, and MI inquiries: Join our webinar for practical insights!
You will learn how to:
Unify MI, AE, PQC for operational efficiency
Standardise forms for better data management
Use MI for compliance and competitive advantage
Collaborate to optimise workflows and reduce disruptions
Our experts, Olga Asimaki, Head of Global Medical Information, and Martijn van de Leur, Chief Operating Officer, will walk you through real-life examples and hands-on solutions.

Видео

Unlocking Success: The FSP Advantage in Clinical Research

52:17

Unlocking Success: The FSP Advantage in Clinical Research

Просмотров 2237 месяцев назад

In this comprehensive webinar, our experts: Irma Ušinskienė, Ineta Šumskienė, and Oleg Kungurtsev, will guide you through all you need to know to achieve success. FSP is a rising trend in clinical research, expected to gain further prominence due to its cost effectiveness and demand for specialised expertise within biopharmaceutical companies. It offers a more targeted approach that allows comp...

Regulatory Outsourcing in the CEE Region

46:14

Regulatory Outsourcing in the CEE Region

Просмотров 18910 месяцев назад

Watch this informative session that promises to decode the intricate landscape of regulatory affairs outsourcing in the CEE region and provide practical, implementable strategies to optimize and maximize your operations and outsourcing strategies.

Benefits of Integrating Pharmacovigilance & Medical Information

1:00:58

Benefits of Integrating Pharmacovigilance & Medical Information

Просмотров 265Год назад

Are you interested in learning about the benefits of integrating Pharmacovigilance and Medical Information? In this webinar, we discuss the advantages of combining these two critical components of drug safety. We discuss how you can achieve this integration by sharing our real-world experience. Shortly? We aim to help you successfully integrate these functions and realize their positive impact ...

Oncology trials in a shifting economical and geopolitical landscape

57:16

Oncology trials in a shifting economical and geopolitical landscape

Просмотров 65Год назад

The pharmaceutical and biotech fields are spinning around, seeking to adapt to the current geopolitical situation and its impact on current and future oncology studies. Many trials have been shifted to other countries or regions while the complexity of managing risk increases. To answer some of the most pressing questions and concerns, we are hosting a webinar discussion where our experts will:...

Setting up a pharmacovigilance system in Europe: Where to start? What to consider?

59:09

Setting up a pharmacovigilance system in Europe: Where to start? What to consider?

Просмотров 540Год назад

Setting up a pharmacovigilance system is not as straightforward an answer as it may sound. There are many aspects to consider, which can seem complicated, especially when you must focus on developing your product. In the first part of this webinar, our experts lay out all the steps necessary to set up a system and discuss best practices in critical areas, including: 1. Regulations and guideline...

How to avoid delays in your early phase oncology trial?

51:37

How to avoid delays in your early phase oncology trial?

Просмотров 702 года назад

The number of oncology clinical trials increases year after year as more treatment options seek to reach the market. However, these studies and becoming progressively more complex, bringing new challenges. Many things can go array in your early phase oncology studies, costing precious time and increasing overall costs. So often, a simple question arises: how to avoid these delays in early phase...

Pharmacovigilance Opportunities in the MENA region

58:50

Pharmacovigilance Opportunities in the MENA region

Просмотров 1442 года назад

How do you effectively guarantee pharmacovigilance in a region that shows significant differences in pharmacovigilance maturity at the country level? Our experts discuss various aspects, including: - An overview of the MENA Region - Available guidelines & Local law - Personal requirements - Comparison to EU/US Pharmacovigilance systems The MENA region holds great promise for the pharmaceutical ...

2:27

Pharmacovigilance Outsourcing

Просмотров 1342 года назад

Pharmacovigilance Outsourcing

Q&A How does the conflict between UA & RU impact the pharma industry?

55:04

Q&A How does the conflict between UA & RU impact the pharma industry?

Просмотров 1252 года назад

Like the rest of the world, the pharmaceutical and biotech industries are beginning to worry about their ability to continue operations. And with good reason. Russia's invasion of Ukraine affects millions of people, not just in this Eastern European nation but throughout the world. There might be delays throughout development, loss of business continuity, and risk of non-compliance for on-marke...

Regulatory Strategy in EAEU and rest of CIS Countries

19:53

Regulatory Strategy in EAEU and rest of CIS Countries

Просмотров 3902 года назад

Regulatory Strategy in EAEU and rest of CIS Countries: Points to Consider for Successful Market Access - Commonwealth of Independent States - CIS countries: EAEU - current status, challenges, practical tips - CIS Countries: NON-EAEU - current status, challenges, practical tips - Focusing on GMP requirements in CIS and EAEU Presentation slides: bit.ly/Regulatory-Strategy-in-EAEU-and-rest-of-CIS-...

eCTD Submission Different Strategies: In-house vs. Outsourcing

19:50

eCTD Submission Different Strategies: In-house vs. Outsourcing

Просмотров 1712 года назад

eCTD Submission Different Strategies: In-house vs. Outsourcing - Understanding requirements for eCTD (different forms of eCTD used EU versus EAEU eCTD; legislation framework; regions/countries following the eCTD) - Different approaches to prepare eCTD submissions: In-house vs. Outsourcing (advantage of outsourcing versus in-house management: optimization of resources with proper experience, inc...

Effective IMPD Writing: The Quality Part

34:00

Effective IMPD Writing: The Quality Part

Просмотров 9732 года назад

In this Webinar, Head of the Central Functions for Regulatory Affairs, Ramunė Rūkienė MSc, and Medical Writer, Eglė Deimantavičiūtė, MSc, will share their experience preparing Quality (CMC) part of the Investigational Medicinal Product Dossier (IMPD) and their advice on effective CMC technical writing. IMPD is a document that contains information about an investigational medicinal product and i...

Successful Medical Device Registration in Russia: The Essentials

47:15

Successful Medical Device Registration in Russia: The Essentials

Просмотров 3392 года назад

The current national system of Medical Device registration in Russia was created from scratch and entered into force in 2013. Most experts agree that this system is complex and puzzling - some critical points are not well documented, some regulatory requirements are ambiguous and unwritten rules play an essential role during the process. The purpose of this webinar is to explain the process and...

Affiliate Based Outsourcing Model for Regulatory Affairs: An Introduction

31:17

Affiliate Based Outsourcing Model for Regulatory Affairs: An Introduction

Просмотров 1922 года назад

In this Webinar, Head of Project Managers for Regulatory Affairs, Claudia Ghislieri, MSc, and Head of Global Regulatory Affairs, Olga Bernardova, MSc, share their experience with the Affiliate Based Outsourcing Model for Local Regulatory Affairs Solutions. Affiliate based Outsourcing Model for Regulatory Affairs works as a replacement or an extension of the company’s internal and local RA resou...