Tagungen und Workshops zum Thema Legislation in der Medizin und Pharmakologie

Wählen Sie ein Land aus:
Belgien (2) - Deutschland (6) - Großbritannien (3) - Indien (3) - Schweiz (1) - Vereinigte Staaten (24)

ALLE LÄNDER

1
Underutilized and Underappreciated in Management Control
21. Feb 2018 • Fremont, Vereinigte Staaten
Zusammenfassung:
Management with executive responsibility is responsible for establishing a quality policy and objectives and for demonstrating a commitment to quality. And management at all levels should be aware of and engaged in quality efforts and customer focus.
Kontakt:
Event Manager;     Tel.: [18004479407];     Email: support@compliance4All.com
Themen:
medical trainings, Compliance trainings, healthcare trainings, Online trainings
Eintrags-ID:
979024
2
Learn Some of the Acceptance Activities in FDA QSR
21. Feb 2018 • Fremont, Vereinigte Staaten
Zusammenfassung:
As you ensure that your Quality Management System meets FDA's regulations, you need robust acceptance activities. A gap could result in a Warning Letter, but even worse, it could also create a recall. This presentation provides the implementation information as well as the audit strategy to help verify your processes.
Kontakt:
Event Manager;     Tel.: [18004479407];     Email: support@compliance4All.com
Themen:
medical trainings, Compliance trainings, healthcare trainings, Online trainings
Eintrags-ID:
979067
3
Workshop — 2 Day Workshop: Preparing For The New EU Medical Device Regulations (MDR)
21. Feb 2018 - 22. Feb 2018 • Hollywood, Vereinigte Staaten
Kontakt:
Conference Manager;     Tel.: [347 282-5400];     Email: support@worldcomplianceseminars.in
Eintrags-ID:
974086
4
Workshop — 2 Days Workshop: Preparing For The New EU Medical Device Regulations (MDR)
21. Feb 2018 - 22. Feb 2018 • Burlingame, CA, Vereinigte Staaten
Zusammenfassung:
The new Medical Device Regulations (MDR) were published in the Official Journal of the European Union on May 5, 2017. From that date, manufacturers, suppliers, Notified Bodies, and national competent authorities have a transition period of three years to comply with the new set of rules. Given the large scale of changes, there is great pressure on all actors to analyze the MDR, conduct impact assessments, and implement compliant processes. After May 2020, non-compliance threatens CE-mark certification, access to the European market, or, in the case of Notified Bodies, re-designation.
Kontakt:
Conference Manager;     Tel.: [347 282-5400];     Email: support@worldcomplianceseminars.com
Eintrags-ID:
1006720
5
Training — Information Governance in Health and Social Care: Ensuring Compliance with GDPR
23. Feb 2018 • London, Großbritannien
Zusammenfassung:
With an opening address from Dawn Monaghan Chair Health and Social Care Working Group on GDPR & Head of Data Sharing and Privacy NHS England, this National Conference focuses on Information Governance in Health and Social Care, ensuring demonstrable compliance with the General Data Protection Regulation (GDPR) which comes into force in May 2018. Through national updates, expert led extended interactive sessions and practical case studies the conference will support you to ensure compliance in your service. Follow this conference on Twitter #GDPRNHS A 20% discount is available by quoting ref: hcuk20c-s when booking.
Kontakt:
8 Wilson Drive, Ottershaw, Surrey KT16 0NT;     Tel.: 0044/1932 429933;     Email: kerry@hc-uk.org.uk
Themen:
Social Care, Data Sharing, Data Protection, Information Sharing
Eintrags-ID:
979483
6
NDAs and INDs for Orally-Administered Drug Products
28. Feb 2018 • Fremont, Vereinigte Staaten
Kontakt:
Event Manager;     Tel.: [18004479407];     Email: support@compliance4All.com
Themen:
medical trainings, Compliance trainings, healthcare trainings, Online trainings
Eintrags-ID:
979088
7
How Ensuring Data Integrity in Method Validations
28. Feb 2018 • Fremont, Vereinigte Staaten
Zusammenfassung:
This section plays a major role in both purchasing and in production. It is a major contributor to determine whether your supplier and manufacturing process are working effectively.
Kontakt:
Event Manager;     Tel.: [18004479407];     Email: support@compliance4All.com
Themen:
medical trainings, Compliance trainings, healthcare trainings, Online trainings
Eintrags-ID:
979021
8
A Legal Compliance Program When Billing Durable Medical Equipment
01. Mär 2018 • Aurora, Vereinigte Staaten
Zusammenfassung:
Learn that treating your Medicare patients with Durable Medical Equipment can be great for patient clinical outcomes, a great revenue stream and can be legally compliant. It will also lower healthcare costs. However one must know how to get the proper licensure and know the Federal & State Guidelines.
Kontakt:
Training Doyens;     Tel.: [7209961616];     Email: support@trainingdoyens.com
Themen:
medical device training programs, medical equipment repair course, medical equipment repair training, medical equipment training
Eintrags-ID:
1015101
9
CfPIE - The Center for Professional Innovation & Education — Product Quality Reviews
01. Mär 2018 - 03. Mär 2018 • Los Angeles, CA, Vereinigte Staaten
Zusammenfassung:
The purpose of the course is to educate the participant in the regulatory requirements for the Annual Product Review while demonstrating the power of the Periodic or Annual Product Review as a Quality Assurance and Quality Improvement tool. We will discuss how the Product Review supports the US, EU and Canadian GMPS while applying the ICH Q10, Pharmaceutical Quality System elements of Process Performance and Product Quality Monitoring, CAPA, Change Management and Management Review, as well as the enablers of Information Management and Risk Management. Discussion will also include the impact of the FDA 2011 Process Validation guidance and the potential impact of the proposed FDA requirement for Quality Metrics on the Product Review.
Kontakt:
Registration Department;     Tel.: [1-610-648-7550];     Email: info@cfpie.com
Themen:
The regulatory requirements for the Annual Product Review The Annual Product Review as it relates to other required and expected reports The Annual Product Review as part of a contemporary Quality System What should be included in the Product Review The Product Review as a source of recommendations for process improvement Management involvement and responsibility The Product Review in support of stage 3 of process validation, continued process verification The Product Review process as a user of, and contributor to, the corporate knowledge The application of quality metrics to the Product Review process
Eintrags-ID:
1006811
10
Training — Clinical Audit Summit 2018: Clinical Audit for Improvement
05. Mär 2018 • London, Großbritannien
Zusammenfassung:
Chaired by Carl Walker Chair National Quality Improvement & Clinical Audit Network (NQICAN) this one day conference will bring together an exceptional gathering of leading practitioners, clinicians, and policy makers to set out the major developments, promote innovative areas of clinical audit, and debate the key challenges affecting you and your clinical audit practice. A series of national updates, best practice case studies, extended sessions and poster presentation will provide you with a practical guide to clinical audit for improvement with a particular focus on developing effective local clinical audit leading to audit recommendations that change practice and improve patient care. Hot topic focus issues this year will be on Clinical Audit Leadership, Mortality Audit and GDPR. Follow this conference on Twitter #ClinicalAudit2018 A 20% discount is available by quoting ref: hcuk20c-s when booking.
Kontakt:
8 Wilson Drive, Ottershaw, Surrey KT16 0NT;     Tel.: 0044/1932 429933;     Email: kerry@hc-uk.org.uk
Themen:
Clinical Audit, Policy and Practice
Eintrags-ID:
1003439
11
Course - The Center for Professional Innovation & Education — Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products
05. Mär 2018 - 06. Mär 2018 • Boston, MA, Vereinigte Staaten
Zusammenfassung:
Whether for biopharmaceutical or pharmaceutical applications, this course presents the technical basics that govern aseptic processing and provides practical advice for attendees to troubleshoot and manage their aseptic operations. Attendees from the sterile medical device industry have also benefited from this training.
Kontakt:
Olivia Carlin;     Tel.: [1-610-648-7550];     Email: info@cfpie.com
Themen:
Risk Management, Containers, Package Integrity, Depyrogenation, Lyophilization, Media Fills
Eintrags-ID:
1013523
12
Workshop — 2018 : 2 Days Conference on UnAnnounced Audits are You Prepared?
08. Mär 2018 - 09. Mär 2018 • Ahmedabad, Indien
Zusammenfassung:
The Indian Pharma industry has been under scrutiny over the last few years and has facedaudits across the year leading to alarming warning letters being received and facing repetitive audits. This has not only impacted reputation of the companies, but it has become imperative for all pharma companies to bring 24/7 quality culture to become all time audit ready.
Kontakt:
Conference Manager;     Tel.: [347 282-5400];     Email: support@worldcomplianceseminars.com
Eintrags-ID:
1003048
13
Workshop — 2018 : 2 Days Conference on UnAnnounced Audits are You Prepared?
08. Mär 2018 - 09. Mär 2018 • Ahmedabad | India, Indien
Zusammenfassung:
The Indian Pharma industry has been under scrutiny over the last few years and has facedaudits across the year leading to alarming warning letters being received and facing repetitive audits. This has not only impacted reputation of the companies, but it has become imperative for all pharma companies to bring 24/7 quality culture to become all time audit ready.
Kontakt:
Conference Manager;     Tel.: [347 282-5400];     Email: support@worldcomplianceseminars.in
Eintrags-ID:
1006785
14
Workshop — 2 Day Workshop: FDA Inspections: What Regulators Expect and How to Prepare
14. Mär 2018 - 15. Mär 2018 • San Diego, Vereinigte Staaten
Kontakt:
Conference Manager;     Tel.: [347 282-5400];     Email: support@worldcomplianceseminars.in
Eintrags-ID:
974041
15
Workshop — 2 Day Workshop: FDA Inspections: What Regulators Expect and How to Prepare
14. Mär 2018 - 15. Mär 2018 • San Diego CA, Vereinigte Staaten
Zusammenfassung:
This is a practical, hands-on course designed to provide pharmaceutical, biopharmaceutical, biologics and medical device professionals with the information and tools they require to prepare for and manage an FDA inspection efficiently, effectively and successfully. Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions.
Kontakt:
Conference Manager;     Tel.: [347 282-5400];     Email: support@worldcomplianceseminars.com
Eintrags-ID:
1006756
16
Pharma Regulatory 2018
15. Mär 2018 • Mumbai, Indien
Zusammenfassung:
Virtue Insight brings you it’s first Pharma Regulatory 2018, focusing on the clarification and interpretation to the most critical regulatory guidelines faced by the Indian Pharma companies.This unique event will bring key stakeholders gather with the aim of promoting and undertaking to continue work towards a more efficient pharma regulatory system. In the spirit of constructive cooperation, this event brings together representatives from the industry and regulators as well as healthcare professionals. The summit features government and regulatory authorities and expert insights to help you tackle and overcome these regulatory challenges, and to improve the drug and device approval processes for pharmaceutical, biopharmaceutical and medical device companies.
Kontakt:
Kavitha;     Tel.: [+91 44 64998743];     Email: kavitha@virtueinsight.co.in
Eintrags-ID:
981984
17
Workshop — 2 Day Workshop: Human Error: Why Human Error is the biggest downtime problem in the manufacturing sector and how to investigate, control, reduce, and prevent to improve results.
15. Mär 2018 - 16. Mär 2018 • Hollywood, Vereinigte Staaten
Kontakt:
Conference Manager;     Tel.: [347 282-5400];     Email: support@worldcomplianceseminars.in
Eintrags-ID:
974095
18
Workshop — 2 Day Workshop: Human Error: Why Human Error is the biggest downtime problem in the manufacturing sector and how to investigate, control, reduce, and prevent to improve results.
15. Mär 2018 - 16. Mär 2018 • New Brunswick, Vereinigte Staaten
Zusammenfassung:
Small mistakes can lead to big disasters—just ask the scientists and engineers who worked on the Mars Climate Orbiter: a $327.6-million USD spacecraft that was destroyed because of a failure to properly convert between units of measurement.Any manufacturer who’s had to shut down an entire production line because someone misread a label or forgot to “carry the one” can sympathize. In fact, according to a new study from Vanson Bourne, manufacturers know the pain of unplanned downtime due to human error better than anyone.
Kontakt:
Conference Manager;     Tel.: [347 282-5400];     Email: support@worldcomplianceseminars.com
Eintrags-ID:
1006758
19
FDA's Medical Device Software Regulation Strategy
20. Mär 2018 - 21. Mär 2018 • Zürich, Schweiz
Zusammenfassung:
The growth of the medical software industry outpaces the design of FDA's regulatory process. In some instances clinicians have weighed the risk of software failure against the benefits of using a device at all. Device software is often used in conjunction with other software-based devices, but their interoperability was never anticipated.Note: Use coupon code and get 20% off on registration and this offer is not valid for with stay registration.
Kontakt:
Referral;     Tel.: [8887172436];     Email: referral@complianceonline.com
Themen:
Seminar by Ex-FDA Official, Regulatory profile for software products, FDA mobile apps regulation, medical device software functionality, FDA and NIST software guidance
Eintrags-ID:
969692
20
Workshop — 1 Day workshop GMP’s in practice: quality systems, common sense compliance, and application
22. Mär 2018 • Washington D.C, Vereinigte Staaten
Zusammenfassung:
This course covers all GMP 211 sub-parts including Part 11 and electronic batch records. Also, this course covers more than 30 elements of a modern quality system, it’s requirements, expectations, and examples. Each element is explored with applicable regulation from US FDA, Health Canada, European Union WHO and ICH (for multinationals).
Kontakt:
Conference Manager;     Tel.: [347 282-5400];     Email: support@worldcomplianceseminars.com
Eintrags-ID:
1003014
21
Workshop — 1 Day workshop GMP’s in practice: quality systems, common sense compliance, and application
22. Mär 2018 • Washington D.C, Vereinigte Staaten
Zusammenfassung:
Course"GMP’s in practice: quality systems, common sense compliance, and application" has been pre-approved by RAPS as eligible for up to 6 credits towards a participant’s RAC recertification upon full completion This course covers all GMP 211 sub-parts including Part 11 and electronic batch records. Also, this course covers more than 30 elements of a modern quality system, it’s requirements, expectations, and examples. Each element is explored with applicable regulation from US FDA, Health Canada, European Union WHO and ICH (for multinationals).
Kontakt:
Conference Manager;     Tel.: [347 282-5400];     Email: support@worldcomplianceseminars.com
Eintrags-ID:
1006777
22
The FDA Drug Approval Process
22. Mär 2018 - 23. Mär 2018 • London, Großbritannien
Zusammenfassung:
This seminar, by a US lawyer with over 40 years of experience dealing with pharmaceutical regulation in the United States and Europe, will provide a general introduction to all aspects of the US drug approval process. It will also cover the organisation and structure of the Food and Drug Administration, recent amendments to the FDA’s procedures designed to expedite the testing and approval of new medicines and other topics of current interest.
Eintrags-ID:
956708
23
2nd Interim Analysis Symposium (EXL)A
26. Mär 2018 - 27. Mär 2018 • Philadelphia, PA, Vereinigte Staaten
Zusammenfassung:
The 2nd Interim Analysis Symposium will provide drug safety and clinical operations teams with best practices and tried-and-true strategies that will enhance the capacity at which organizations can produce upstanding reports about the results of their ongoing studies and expedite effective products to market.
Eintrags-ID:
956972
24
2nd Product Complaints Forum (EXL)A
26. Mär 2018 - 27. Mär 2018 • Philadelphia, PA, Vereinigte Staaten
Zusammenfassung:
ExL Events’ 2nd Product Complaints Forum will provide insight into how to improve the management of product complaints and potential recalls. This program will feature case studies, panel sessions, and two tracks designed to deliver information for pharmaceutical, biotechnology, and medical device professionals involved in all stages of handling product complaints and potential recalls.
Eintrags-ID:
957048
25
CfPIE - The Center for Professional Innovation & Education, Inc. — Computer System Validation
12. Apr 2018 - 13. Apr 2018 • Berlin, Deutschland
Zusammenfassung:
This computer system validation course focuses on developing and implementing regulated computer systems with an appropriate level of documented evidence to satisfy FDA expectations. The course targets deliverable document content and how to avoid rework and unnecessary expense through a proactive approach. The core elements of a satisfactory computer validation program will be emphasized.
Kontakt:
Olivia Carlin;     Tel.: [1-610-648-7550];     Email: info@cfpie.com
Themen:
21 CFR part 11, computer validation, GAMP 5, Auditing GXP, Part 810, Part 211, Q7A GMPs, Software Validation
Eintrags-ID:
1010005
Verwandte Fachgebiete:
26
CfPIE - The Center for Professional Innovation & Education — Good Manufacturing Practices Training | GMP Course
18. Apr 2018 - 20. Apr 2018 • Berlin, Deutschland
Zusammenfassung:
This Good Manufacturing Practices training covers the foundations of the regulations that control the manufacture and distribution of pharmaceutical, biologic and medical devices sold in the United States. Current Good Manufacturing Practices (cGMPs) are defined for all Food and Drug Administration (FDA) Regulated products in Title 21 CFR 210/211. Application of the regulations will be discussed and examples provided throughout the GMP course. Attendees will gain an understanding of how knowledge of the regulations facilitates efficient and cost effective production and problem resolution.
Kontakt:
Olivia Carlin;     Tel.: [1-610-648-7550];     Email: info@cfpie.com
Themen:
GMP, Change Control, Master Plan, Laboratory Controls
Eintrags-ID:
1010059
Verwandte Fachgebiete:
27
Workshop — 2 Day Workshop Product Registration and Navigating the Approval Process with Regulatory Authorities in Asia Pacific, Europe, Middle East and The Americas
25. Apr 2018 • Boston, Vereinigte Staaten
Kontakt:
Conference Manager;     Tel.: [347 282-5400];     Email: support@worldcomplianceseminars.in
Eintrags-ID:
974105
28
Workshop — 2 Day Workshop Product Registration and Navigating the Approval Process with Regulatory Authorities in Asia Pacific, Europe, Middle East and The Americas
25. Apr 2018 - 26. Apr 2018 • Boston,MA, Vereinigte Staaten
Zusammenfassung:
Description

One of the first steps towards selling a Class II medical device or IVD in the United States is to file a Premarket Notification with the FDA, also known as an FDA 510(k) submission. Technically, the FDA does not "approve" medical devices or IVDs for sale under the 510(k) process; the agency gives "clearance" for them to be sold in the U.S. We use the term "FDA approval" for simplicity. Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.

Kontakt:
Conference Manager;     Tel.: [347 282-5400];     Email: support@worldcomplianceseminars.com
Eintrags-ID:
1003023
29
Workshop — Current issues in assuring data integrity in life sciences : 2 Days Seminar
25. Apr 2018 - 26. Apr 2018 • San Diego CA, Vereinigte Staaten
Zusammenfassung:
Data Integrity is a major concern of regulatory agencies worldwide as evidenced by the increasing number of Warning Letters issued in that area. Some managements have proceeded to implement data integrity programs on the lines of those implemented in “big data”. This has resulted in the escalation of costs and it is disproportionate to the benefits gained. Some even wonder why they continue to receive Warning Letters in spite of spending the dollars to implement programs such as Data Governance etc. etc.
Kontakt:
Conference Manager;     Tel.: [347 282-5400];     Email: support@worldcomplianceseminars.com
Eintrags-ID:
1006693
30
Workshop — 2 Day Workshop Product Registration and Navigating the Approval Process with Regulatory Authorities in Asia Pacific, Europe, Middle East and The Americas
25. Apr 2018 - 26. Apr 2018 • Boston,MA, Vereinigte Staaten
Zusammenfassung:
One of the first steps towards selling a Class II medical device or IVD in the United States is to file a Premarket Notification with the FDA, also known as an FDA 510(k) submission. Technically, the FDA does not "approve" medical devices or IVDs for sale under the 510(k) process; the agency gives "clearance" for them to be sold in the U.S. We use the term "FDA approval" for simplicity. Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.
Kontakt:
Conference Manager;     Tel.: [347 282-5400];     Email: support@worldcomplianceseminars.com
Eintrags-ID:
1006746
31
CfPIE - The Center for Professional Innovation & Education — CMC Regulatory Compliance for Biopharmaceuticals & Biosimilars
23. Mai 2018 - 25. Mai 2018 • Berlin, Deutschland
Zusammenfassung:
This course will help the attendee to develop a CMC regulatory compliance strategy for biopharmaceuticals, biosimilars and other biologics, addressing the five core elements that comprise an effective strategy: (1) embracing the full spectrum of CMC activities, (2) addressing unique requirements for specific biologic manufacturing processes, (3) addressing unique requirements for specific biologic products, (4) aligning with the strategic ICH Q8/Q9/Q10 guidances, and (5) applying a clinical phase-appropriate approach. The critical importance of communicating CMC regulatory compliance strategy with the regulatory authorities at CMC-focused meetings will be stressed. In addition, this course will also help the attendee to better understand the CMC regulatory compliance requirements for Quality by Design applications and for biosimilars.
Kontakt:
Olivia Carlin;     Tel.: [1-610-648-7550];     Email: info@cfpie.com
Themen:
compliance, biologics, FDA, EMA, regulatory review pathways, IND, NDA, BLA, MAA
Eintrags-ID:
1010029
Verwandte Fachgebiete:
32
CfPIE - The Center for Professional Innovation & Education — Preparing the CMC Section for MAAs, IMPDs
30. Mai 2018 - 31. Mai 2018 • Berlin, Deutschland
Zusammenfassung:
This course includes an overview of the relevant guidelines and the organization of the CTD, detailed information and discussions related to each element required in the drug substance and drug product sections of MAAs. The course will emphasize the requirements related to drug substance starting materials, drug substance and drug product specifications, impurities, stability, manufacturing and pharmaceutical development. It will also discuss the use of Drug Master Files (DMF), Certificates of Suitability (CEPs) and preparation of the CTD Quality Overall Summary (Module 2).
Kontakt:
Olivia Carlin;     Tel.: [1-610-648-7550];     Email: info@cfpie.com
Themen:
MAA, CTD, drug substance, purity, stability, DMF, Certificates of Suitability, CEP, CMC, chemistry manufacturing and controls
Eintrags-ID:
1010012
Verwandte Fachgebiete:
33
4th Annual ComplianceOnline Medical Device Summit 2018
07. Jun 2018 - 08. Jun 2018 • San Francisco, Vereinigte Staaten
Zusammenfassung:
Plan for successfully executing regulatory inspections by providing industry best practices. Panel discussions led by the former FDA office bearers and industry experts will provide a set of comprehensive strategies on how to prepare for and manage an FDA inspection, including how to follow-up and closing out 483s or Warning Letters. Attending this summit will enable you to improve and better prepare for your next inspections.
Kontakt:
Referral;     Tel.: [8887172436];     Email: referral@complianceonline.com
Eintrags-ID:
954518
34
Gordon Research Seminar — Drug Safety
09. Jun 2018 - 10. Jun 2018 • Stonehill College, Easton, MA, Vereinigte Staaten
Themen:
Drug Safety in the Modern Development Landscape: Innovations from Industry, Academia, and Government
Eintrags-ID:
960033
35
Gordon Research Conference — Drug Safety
10. Jun 2018 - 15. Jun 2018 • Stonehill College, Easton, MA, Vereinigte Staaten
Themen:
Contemporary Advances and Challenges in Drug Safety Assessment
Eintrags-ID:
960067
36
Course — European Regulatory Procedures - EMA & National Requirements
13. Sep 2018 - 14. Sep 2018 • Berlin, Deutschland
Zusammenfassung:
This course will give participants the necessary overview of the application procedures and regulatory filing pathways used within Europe to grant marketing authorisations for medicinal products, and of the agencies and institutions that control the regulatory process. Special focus will be given to the European Medicines Agency (EMA) and the Centralised Procedure (CP), with the role of the national health authorities and other EU bodies in the Mutual Recognition Procedure (MRP) and Decentralised Procedure (DCP) explained also. Factors affecting the choice of procedure will be discussed, as well as best practice in the management of the procedures. A workshop session will engage participants in a case study evaluating the options for submission of a marketing authorization application.
Kontakt:
Olivia Carlin;     Tel.: [+1-610-648-7550];     Email: info@cfpie.com
Themen:
European Regulatory Procedures, Regulation, EMA, Centralised Procedure, European Medicines Agency, Filing Strategy, Labeling
Eintrags-ID:
1012395
Verwandte Fachgebiete:
37
The Pharma Licensing Negotiation Course
27. Sep 2018 - 28. Sep 2018 • Brüssel, Belgien
Zusammenfassung:
Learn and practice in role plays the whole armamentarium of winning strategies, tools, dos & don’ts, tricks & tips in each step of the pharma licensing negotiation process: planning – internal negotiations – making the first contact – term sheet assumptions – face-to-face meetings – resolving issues – contract closure.
Kontakt:
Annelies Swaan;     Tel.: [+32 2 709 01 42];     Email: annelies.swaan@celforpharma.com
Eintrags-ID:
1009922
38
Course — Filing Variations in the European Union
07. Nov 2018 - 08. Nov 2018 • Berlin, Deutschland
Zusammenfassung:
The course is designed to provide individuals with an in-depth awareness of the rules and procedures for filing variations and extensions. Understanding and applying the rules will ensure that you can file the variations successfully and avoid rejections.
Kontakt:
Olivia Carlin;     Tel.: [+1-610-648-7550];     Email: info@cfpie.com
Themen:
filing, extensions, Marketing Authorizations, filing variations, CMD, Submission, Timeline
Eintrags-ID:
1012484
39
The Pharmaceutical Out-licensing Course
27. Nov 2018 - 28. Nov 2018 • Brüssel, Belgien
Zusammenfassung:
Be able to decide on the best deal type for products in R&D – Know what to include in CDAs, MTAs and term sheets – Learn how to prepare product information and how to find potential partners – Know how to calculate the value of your product and optimise the deal structure.
Kontakt:
Annelies Swaan;     Tel.: [+32 2 709 01 42];     Email: annelies.swaan@celforpharma.com
Eintrags-ID:
1009932


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AIP Conference Proceedings
AIP Conference Proceedings

Stand vom 12. Februar 2018