Meet Our Experts.
In Life Sciences Webinars.
Whether you’re a healthcare professional, a researcher, or simply interested in the drug development, you’ll find valuable information and resources here that can help you stay informed and make informed decisions. Let us know what else you’d like to hear about!
Regulatory Outsourcing in the CEE Region
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
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 on your operations and patient outcomes.
Oncology trials in a shifting economical and geopolitical landscape
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.
Even though managing your studies in these economic times might seem challenging, all you need is thoughtful preparation and adaptation measures. Our experts will share practical tips and experience-based results on how you can do it too.
Setting up a pharmacovigilance system in Europe: Where to start? What to consider?
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.
Our experts lay out all the steps necessary to set up a system and discuss best practices in critical areas. Additonally, we dive into actual best practices to overcome day-to-day challenges.
Regulatory Framework of Drugs in MENA: Insights
In this webinar, our experts discuss regulatory affairs of medicinal products. Two aspects that have recently gained increasing importance among the various stakeholders, namely the eCTD implementation across the region and the serialization and barcoding requirements for medicinal products.
So, we share our insights on these two aspects and share how you can avoid various issues in drug registration.
How to avoid delays in your early phase oncology trial?
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 oncology studies?
Pharmacovigilance Opportunities in the MENA region
Together the 22 MENA countries have a 350 million population that spends over $30 billion on pharmaceutical products per year and show robust growth. However, it is not a simple task to enter this market due to various factors, including the lack of a centralized pharmaceutical regulator.
How do you effectively guarantee pharmacovigilance in a region that shows significant differences in pharmacovigilance maturity at the country level?
Q&A How does the conflict between UA & RU impact the pharma industry?
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-market products.
Our experts dive into the question ‘How does the conflict between UA & RU impact the pharma industry?’.
Regulatory Strategy in EAEU and rest of CIS Countries
Navigating market access in the Commonwealth of Independent States (CIS), both within the Eurasian Economic Union (EAEU) and beyond, necessitates understanding their unique challenges and opportunities. Central to this is the adherence to Good Manufacturing Practice (GMP) requirements across these regions.
Our webinar provides practical insights into regulatory strategies for successful market entry in the CIS, focusing on current scenarios and high manufacturing standards.
eCTD Submission Different Strategies: In-house vs. Outsourcing
Understanding the complexities of eCTD (electronic Common Technical Document) submissions is vital for choosing the optimal approach: in-house or outsourcing. Both options have distinct merits, with outsourcing offering expert resources and cost-effectiveness, while in-house control ensures direct oversight.
Our webinar discusses these strategies, the need for technical resources, and the importance of validating submissions for compliance, providing practical tips for quality submissions regardless of the chosen strategy.
Effective IMPD Writing: The Quality Part
IMPD is a document that contains information about an investigational medicinal product and it is an essential part of the Clinical Trial Application (CTA), which is required by competent authorities in EU.
The purpose of this webinar is to share the best practices in the preparation of IMPD in order to meet the expectations of competent authorities and to learn why effective CMC technical writing is critical for the development of a high quality IMPD.
Successful Medical Device Registration in Russia: The Essentials
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 share the experience in the field of Medical Device registration in Russia.
Affiliate Based Outsourcing Model for Regulatory Affairs: An Introduction
Affiliate based Outsourcing Model for Regulatory Affairs works as a replacement or an extension of the company’s internal and local RA resources. Many challenges come up from managing your RA activities as sometimes their processes are not harmonized across different countries, the resources are not cost-optimized or simply there isn’t enough of them.
The purpose of this webinar is to share practical tips and insights on the effective optimization of local RA setup, management and relevant costs.
Medical Device Registration in Russia: Challenges and Issues
This webinar navigates the complex terrain of Medical Device registration in Russia. We will explore unique national classifications that differentiate between medical devices in the EU and Russia, discuss challenges in registering complex and multi-component devices, and understand the Russian approach to Software as a Medical Device (SaMD).
This session is designed to demystify Russian regulations, providing insights to conquer challenges in medical device registration.
Strategic Pharmacovigilance Activities: Scalable and Tailor-made Outsourcing Models
Larger companies often limit their pharmacovigilance outsourcing only to highly manual and repetitive tasks, while the smaller ones may want to outsource their entire pharmacovigilance system. But is there anything in between?
This webinar shares insights on strategic PV outsourcing that can be personalized for any needs or requirements:
