Events for „Pharma / Medical devices“

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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
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.

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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.

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Medical Writing in Pharmacovigilance

Enhance your skills in writing key pharmacovigilance safety documents. In this two-day online seminar, gain not just a broad understanding of the regulatory requirements and guidelines, but also practical experience in crafting and maintaining PSUR, RMP, and DSUR. Learn best practices, discover common pitfalls, and tackle global challenges to become a proficient "Pharmacovigilance Writer"!

online 06-07/06/2024
Pharmacovigilance Requirements in China - LATAM - EAEU - MENA

Regulatory expectations regarding risk management for pharmaceuticals in (emerging) markets often contend with the stringent standards set by the EU/ICH regions. Join us in five consecutive webcasts to gain insights into local pharmacovigilance systems in different countries and regions, and learn how to integrate them into your global PV system while maintaining a clear overview!

online 10-11/06/2024
Biopharmaceuticals

LAST CALL! - CANCELLATION DEADLINE: 07.06.2024 - 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 = 1.190€ plus VAT) - for booking, please contact us!

online 24-26/06/2024
Artificial Intelligence in Pharmacovigilance

Artificial intelligence is being hailed as the next key innovation. This course will show you how to integrate suitable systems and applications into your daily workflow and simplify business processes between your PV and IT departments using AI. Register now to stay ahead.

online 05/07/2024
Masterclass China: Medical Device Marketing Authorisation for Advanced

Interested in establishing a strong presence in the Chinese medical devices market? Join our training to gain valuable insights into the latest Chinese regulations governing medical devices, and discover strategies to optimize your pre-market registration and post-market surveillance. Benefit from the expertise of our local specialists, who will share up-to-date information to enhance your success

online 10-11/09/2024
Webcast series "From Lab to Launch: Technical CMC and Non-Clinical Development of RNA/DNA-based drugs"

RNA-/DNA-based drugs: gain a solid understanding of the complexities involved in the development and regulatory approval of RNA-based drugs and oligonucleotides. Meet outstanding and longtermin experienced experts in the field of research.

online 11/09/-11/12/2024
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 17-18/09/2024
Joint Clinical Assessments - Count down EU-HTA

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

online 24/09/2024
GxP-Regulated Archiving

Get practical expertise for the GMP, GLP and GCP-compliant archiving of relevant documents and the efficient integration of the archiving system into your daily work processes. The three experts will show you some practical approaches to typical pitfalls.

online 24/09/2024
Marketing Authorisation in Latin America

An online seminar to discuss real cases/challenges for marketing authorisation in Mexico, Argentina, Colombia, Peru, Chile and Brazil with local experts from Brazil and Spain.

online 26-27/09/2024
Mastering FDA inspections: Preparation and Best Practices

FDA inspection readiness: Gain the knowledge and skills necessary to manage future FDA inspections with confidence and ease.

online 15/10/2024
CMC dossier requirements for biologics: FDA vs EU

CMC requirements in the US: After having attended the seminar you will feel secure writing and maintaining the quality dossier for US marketing authorisations of large molecules/biologics.

online 16/10/2024
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
CMC for Biologicals

Get your know-how on creating and maintaining quality data for biotech products in our online training.

online 04/11/2024
RMP and PSUR in lifecycle management: An art, not a miracle

Do you already have a good understanding of PSUR and RMP including risk minimisation measures and would like to deepen, broaden and update your knowledge? Then this course is for you! Learn about pharmacovigilance requirements in the drug lifecycle and their impact on RMP and PSUR from a global perspective. Save your place now!

online 06/11/2024
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 12-13/11/2024
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 12-13/11/2024
Generic Drugs: Market Access and Pricing in Europe

Success in generic drug market access and pricing in Europe - register now!

online 19/11/2024
Pharmacovigilance Auditing

Do you want to independently plan and conduct pharmacovigilance audits? Then take this opportunity to become an "Auditor for Good Pharmacovigilance Practices". Secure your place on our compact, interactive online course. Book now!

online 25-26/11/2024
Mastering ICH Quality Guidelines: From Development to Lifecycle Management

To make the most of ICH Q12 opportunities, you have to be aware of the relation between ICH guidelines Q8 to Q12 and how to properly integrate them. Our experts will go through each guideline and train you on the desired outcome of mastering the processes from development to lifecycle management and especially QbD.

online 28/11/2024
PharmaFORUM Webcast Biologics 2024

Our biotech experts will provide you with the latest information on issues related to development, quality and regulatory affairs of biologics every month in a two-hour webcast, in particular with regard to CMC.

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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
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.

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e-Learning: CTD Module 3

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

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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.

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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...).

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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.

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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!

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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.

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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.

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