Events for „Pharma / Medical devices“

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Qualification course: Global Regulatory Affairs Manager

With this qualification course, you can continue your education in a structured manner in all global regulatory affairs topics, with a regional or country-specific focus.

online 01/01/-31/12/2024
Qualification course: CMC-Specialist in Regulatory Affairs

With this qualification course, you can continue your education in a structured manner in all CMC topics, with a technical focus on development methods, manufacturing processes, CMC documents, change management, and much more.

online 01/01/-31/12/2025
PharmaFORUM Webcast International

Our global and local experts will update you every two months with the latest regulatory and legislative developments. Thus, you will always have the essential information and trends in regulatory affairs at your fingertips!

online
Your pre-meeting: Be prepared for your event

Attend one of our free pre-meetings to familiarise yourself with the Learning Space and the various ways in which you can interact during the event

online
Vendor Oversight and Quality Management in RA and PV

Outsourcing of activities, tasks or positions in regulatory affairs and pharmacovigilance is often standard practice. In this seminar, you will not only learn all you need to work with service providers, but also how to set up and monitor an effective vendor oversight programme in practice.

online 04-05/12/2024
Preclinical development: From bench to first in human

Preclinical drug development: The online training course for preclinical newcomers with a focus on small molecules and biologics. Learn about the fundamentals and regulatory requirements and take the opportunity to discuss the challenges in your practice with our experts and industry colleagues.

online 09-11/12/2024
CMC requirements in Latin America

CMC requirements in Latin America with focus Mexico, Brazil, Colombia, Argentina, Chile, and Peru. The seminar (2 half days) is comfortable to integrate into your daily work routine.

online 10-11/12/2024
Drug Market Access & Pricing in Europe

Online seminar on Market Access & Pricing in Europe - this is how you can gain access as a pharmaceutical manufacturer!

online 10-11/12/2024
Regulatory Lifecycle Management

This course familiarises you with regulatory post-approval duties and provides first-hand information on variation submission, PV activities and labelling changes.

online 11/12/2024
online 04/06/2025
e-Learning: EU Variation System and Procedures

This e-Learning programme will provide you with detailed knowledge on the classification, grouping and submission of variations in the EU.

online
e-Learning: Common Technical Document and eCTD

Do you need know how regarding CTD/eCTD & CMC? Then this e-learning programme is the fast track to becoming knowledgeable in this field. No prior dossier experience is required.

online
e-Learning: Introduction to EU Marketing Authorisation

This e-learning programme will familiarise you with the regulatory affairs principles involved in applying for a marketing authorisation in Europe (MRP, DCP, CP) . It will also introduce you to post-authorisation duties (renewal, variation...).

online
e-Learning: Reimbursement for the German Healthcare Market

This e-learning provides a comprehensive understanding of reimbursement in the German healthcare market, covering outpatient and inpatient sectors, digital health applications, and upcoming changes like hybrid DRGs and hospital reform. Stay informed and up-to-date on these significant changes in the German healthcare system.

online
e-Learning: Market Access for Medical Devices - The NUB Process

The e-learning provides a comprehensive understanding of the German healthcare system, market access and reimbursement of medical devices, with a particular focus on the NUB process. Get insider knowledge from our speaker and place your product successfully on the German market.

online
e-Learning: Medical Device Advisor (MPDG)

With our e-learning specially tailored to medical device consultants, you will receive the knowledge essential for medical device advisors - so that you can move about in your everyday professional life with legal certainty!

online
Artificial Intelligence in Pharmacovigilance

Explore the transformative potential of artificial intelligence in pharmacovigilance. This course provides an in-depth understanding of AI technologies, regulatory requirements, and practical applications in drug safety. Through expert insights and hands-on workshops, you'll learn how to leverage AI to enhance your pharmacovigilance processes. Register now to future-proof your PV operations.

online 20/01/2025
online 10/07/2025
German Health Advertisement Law - Topics of special interest

Get to know the legal peculiarities of German pharmaceutical advertising!

online 22/01/2025
The Pharmacovigilance System Master File (PSMF) in a Global Environment

This online-seminar will provide tips on how to prepare and maintain a core PSMF as well as annexes with the relevant local peculiarities worldwide. Register today!

online 23/01/2025
The EU Qualified Person for Pharmacovigilance (EU QPPV)

Update your knowledge: Our team of experts provides you with important and practical information about the tasks and responsibilities of an EU-QPPV.

online 11/02/2025
Toxicology and beyond: Safety assessment in drug development

During our online training "Toxicology and beyond: Safety assessment in drug development" you will build a solid toxicological know-how basis and will be informed about the inclusion of toxicological data in the marketing authorisation dossier. Take the chance and participate in our interactive online training.

online 17-18/02/2025
CMC Writing

You as "beginner" or "refresher" would like to feel more secure writing CMC documents? Our experts will provide you with practical tips and tricks and share their experiences with you. After attending this virtual seminar you will be able to present data clearly and in compliance with the regulations.

online 18/02/2025
Regulatory Compliance in Clinical Trials

Are you looking for a compact knowledge update on the regulations and guidelines in clinical drug trials to perform your daily work in a compliant and responsible manner? Then get comprehensive information in this webcast series!

online 24-25/02/2025
GMP essentials for quality management

ATTENTION: Date change - now 25-26 February 2025 - Will you be involved in the implementation and sustainable maintenance of the quality management system in your pharmaceutical company in the future? Our experts will provide you with the essential understanding of the subsystem of good manufacturing practice in this seminar. Also suitable as an update for experienced specialists.

online 25-26/02/2025
Global variations and lifecycle management

Global variations and lifecycle management - covering key regions: USA, Asia (China, Japan, South Korea), LATAM (Central America, Brazil), and Gulf Cooperation Council (GCC). Take this opportunity to discuss your specific daily business challenges with our experts and network with peers to see how others approach similar issues!

online 25/02/-25/03/2025
Webcast: Global Medical Device Registration

This webcast series is designed for professionals seeking to gain a clear understanding of market access for medical devices and technologies in China, Saudi Arabia, Switzerland, and the UK. The sessions are concise, focused, and include the added benefit of addressing your specific questions.

online 05/03/-06/05/2025
Individual Case Safety Reports (ICSRs)

Reporting adverse drug reactions forms the foundation of drug safety. In this one-day online seminar, you will learn the regulatory requirements and best practices for ICSR reporting. Whether you are new to the topic or looking for a refresher, you will benefit from the extensive practical experience of our speakers from both Big Pharma and consulting!

online 10/03/2025
Global Regulatory Affairs Manager

This online seminar provides a comprehensive overview of global regulatory affairs, covering strategies for setting regulatory policies, developing global regulatory dossiers, understanding HTA interfaces, enhancing global communication, and staying updated on ICH guidelines, ISO IDMP updates, and global regulatory trends.

online 10-11/03/2025
All about ATMP

The online seminar with details on development, quality, CMC, approval and market access (including an update on the upcoming EU HTA) for advanced therapy medicinal products. Qualifiy now!

online 12-13/03/2025
JCA Dossiers & Joint Clinical Assessments

Here you will get the latest information on the process of joint clinical assessments, including scoping and JCA dossier preparation.

online 24/03/2025
Global Pharmacovigilance Inspection Readiness

Learn how to prepare your pharmacovigilance system in Germany, Europe and worldwide for an upcoming inspection in this one-day online course. Gain a comprehensive understanding of the EMA's Good Pharmacovigilance Practice (GVP/GPvP) modules, strategic and remote planning and preparation, and differences in GVP inspections around the world. Reserve your seat in our virtual seminar room.

online 24/03/2025
Qualification Course: EU Regulatory Affairs Manager

Participants in this qualification course will receive thorough training on the main regulatory duties, from marketing authorisation applications to lifecycle management. This is the ideal preparation for starting a career in drug regulatory affairs. After course completion a certificate will be awarded.

online 26/03/-04/06/2025
Pharmaceutical industry in transition: The importance of AI for quality & efficiency

Pharmaceutical industry in transition: The importance of AI for quality & efficiency - Artificial Intelligenge in GxP-/ISO-regulated areas.

online 27/03/2025
Regulatory Affairs and CMC Conference

The conference will cover recent updates and practical implications of the EU pharmaceutical legislation, management of supply shortages, and the new EU Variation regulation. Additionally, it will address the latest developments in quality guidelines, impurities (with a focus on nitrosamines), and the application of AI in CMC and quality processes.

online 02/04/2025
Best practice: project management in GxP

Project management in GxP - Managing projects successfully and efficiently in a regulated environment!

online 08/04/2025
Marketing Authorisation Procedures in the EU

This seminar provides an in-depth exploration of EU drug marketing authorisation, focusing on regulatory frameworks, application types and procedures. It covers mutual recognition, decentralised and centralised procedures (MRP, DCP, CP) in detail, providing essential insights for successful EU drug approval.

online 09/04/2025
Global Labelling and Company Core Datasheet (CCDS)

Attend this seminar to gain in-depth knowledge of the CCDS concept, global labelling requirements, and practical insights into market-specific regulations in the EU and USA.

online 11/04/2025
An Introduction for Pharmacovigilance Managers

Are you new to pharmacovigilance and looking to kick-start your career? Then this online course is just for you. Gain a comprehensive overview of pharmacovigilance, regulatory requirements in the EU and implementation in only two days. Book now!

online 28-29/04/2025
Webcast series: Global regulatory requirements for drug device combination products (DDCs)

Global regulatory requirements for drug device combination products (DDCs): You will receive a regulatory overview for the EU, the US, China, MENA, Mexico and other LATAM countries, plus you will obtain tips and tricks by (local) experts on how to speed up the approval process.

online 29/04/-27/08/2025
Marketing Authorisation Documents in the EU

This seminar provides an in-depth exploration of the marketing authorisation dossier and the electronic submission process, focusing on the CTD structure and modules 1-5. Participants will gain practical knowledge and strategies for successful drug approval applications in the EU.

online 08-09/05/2025
Pharmacometrics modeling in Monolix

Pharmacometric modeling in Monolix - various (guided) hands-on units included. After having participated in the hands-on course you will be prepared to tackle real-world challenges in pharmacometrics, ultimately improving your contributions to disease modeling and drug development projects.

München 15-16/05/2025
Medical Writing in Pharmacovigilance

Enhance your skills in writing key pharmacovigilance safety documents. In this two-day online seminar, you will gain a comprehensive understanding of the regulatory requirements and hands-on experience in crafting and maintaining PSUR, RMP, and DSUR. Learn best practices, avoid common pitfalls, and address global challenges to become a proficient "Pharmacovigilance Writer"!

online 19-21/05/2025
CMC Management in Regulatory Affairs

This online training will give you in-depth knowledge on the CMC requirements for marketing authorisation. Take the chance to participate in our virtual seminar and get qualified.

online 22-23/05/2025
Biopharmaceuticals

The compact course with a content focus on the development, production and analytics of biotech drugs. Secure your place and qualify now! All three course days can be booked individually (single day = 1.290€ plus VAT) - for booking, please contact us!

online 03-05/06/2025
Regulatory Lifecycle Management

This course familiarises you with regulatory post-approval duties and provides first-hand information on variation submission, PV activities and labelling changes.

online 04/06/2025
online 11/12/2024
Artificial Intelligence in Pharmacovigilance

Explore the transformative potential of artificial intelligence in pharmacovigilance. This course provides an in-depth understanding of AI technologies, regulatory requirements, and practical applications in drug safety. Through expert insights and hands-on workshops, you'll learn how to leverage AI to enhance your pharmacovigilance processes. Register now to future-proof your PV operations.

online 10/07/2025
online 20/01/2025
Hot Topics Related to Quality in Herbal Medicinal Products

Experts from national competent authorities speak about the current developments with regard to e.g. the revision of guidelines (GACP, Variation Regulation, Variation Classification Guideline), the changes of procedures and corresponding chances (MRP/DCP), and the use and "impact" of new evaluation methods (Real World Data). The authority's prespective is complemented by industry's experiences.

online 27/11/2025
e-Learning: CTD Module 3

This e-Learning programme will familiarise you with the data requirements in CTD Module 3.

online
e-Learning: Stability Testing in the ICH Region

This e-Learning programme will focus on stability testing for chemical and biological products in the ICH region.

online