Conferences and Meetings on Regulation in Medicine and Pharmacology

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Belgium (2) - Germany (6) - India (1) - Italy (1) - United Arab Emirates (2) - United Kingdom (3) - United States (21)

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1
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, United States
Contact:
Conference Manager;     Phone: [347 282-5400];     Email: support@worldcomplianceseminars.in
Event listing ID:
974083
2
4 MMF — 4th MENA MedTech Forum
25 Apr 2018 - 26 Apr 2018 • Dubai, United Arab Emirates
Abstract:
The MENA MedTech forum is the most prominent event in health and medical technology industry in the Middle East and North Africa region.
Contact:
Epin Kurra;     Phone: [97144218996];     Email: MMF@InfoPlusEvents.com
Topics:
Ethical Practice, Market Stream Access, MENA MedTech Forum
Event listing ID:
1053341
3
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, United States
Abstract:
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.

Contact:
Conference Manager;     Phone: [347 282-5400];     Email: support@worldcomplianceseminars.com
Event listing ID:
1003078
4
Workshop — Current issues in assuring data integrity in life sciences : 2 Days Seminar
25 Apr 2018 - 26 Apr 2018 • San Diego CA, United States
Abstract:
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.
Contact:
Conference Manager;     Phone: [347 282-5400];     Email: support@worldcomplianceseminars.com
Event listing ID:
1006759
5
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, United States
Abstract:
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.
Contact:
Conference Manager;     Phone: [347 282-5400];     Email: support@worldcomplianceseminars.com
Event listing ID:
1006768
6
Keystone Symposia Free Webcast: Drug Discovery - Current Trends in Medicinal Chemistry
26 Apr 2018 • online, United States
Abstract:
Today’s armamentarium of therapeutic products has expanded dramatically in recent years to include a cadre of biologics, such as antibodies, in addition to traditional small molecule chemicals (“drugs”). Nonetheless, nearly all of the top 100 most prescribed therapeutics continue to be small molecule drugs. Thus, drug discovery and its core disciplines – including medicinal chemistry – remain a hotbed of innovation. Given the continued importance of drug discovery, we assembled a diverse panel of practicing “drug hunters”.
Contact:
Attendee Services;     Phone: [970.262.1230];     Email: info@keystonesymposia.org
Topics:
drug development, drug discovery, biologics, pharmacology, medicinal chemistry
Event listing ID:
1043088
7
FDA's GMP Expectations for Phase I and First-in-Man Clinical Trials
03 May 2018 - 04 May 2018 • Tampa Marriott Westshore, FL, United States
Abstract:
Review the FDA recommendations and requirements for implementing a compliant program for the phase 1 clinical program.
Event listing ID:
1046891
Related subject(s):
8
FDA’s Expectations from Supplier Management for GMP: Quality Agreements and More
10 May 2018 • Palo Alto, United States
Abstract:
Failure to adequately assess and control your supplier/subcontractor pool can result in dire consequences for an organization. Assessing and approving your suppliers before placing the first order with them will eliminate many headaches for a medical device manufacturer.

While all of these reasons have varying degrees of validity, none of them articulate the best reason for having a robust supplier audit program. A good supplier audit program should allow an organization to assess and periodically re-affirm the ability of key suppliers to provide conforming product consistently, reliably and on-time. It should be one of the most important initiatives toward fulfilling the goal of having a sustainable supply chain.

Contact:
Ashutos Swain;     Phone: [888-717-2436];     Email: referral@complianceonline.com
Topics:
FDA supplier management training, supplier quality management, supplier quality agreement, supplier selection, supplier audits
Event listing ID:
1053761
9
FDA’s GMP Expectations for Phase I and First-in-Man Clinical Trials
10 May 2018 - 11 May 2018 • Boston, United States
Abstract:
Manufacturing an investigational product for the initial pilot clinical trials could pose a considerable logistical and financial challenge to developers. The first-in-man and pilot clinical trials are usually conducted in very small number of healthy participants with lower doses primarily to establish safety and hence do not need a significant amount of investigational material. The US FDA allows developers to test early stage investigational products under relaxed GMP requirements. The manufacturing requirements for early stage clinical trials are designed to assure adequate quality of the investigational product being tested without the excessive regulatory burden of full-scale GMP manufacturing. This workshop will present the current regulations, guidance documents and regulatory strategies available for manufacturing an early development stage product for Phase I and first-in-man clinical trials. Also discussed will be logistical issues with managing the supply of an early stage investigational product, and requirements for stability testing, storage and shipping, labeling, and documentations. Perspectives for different classes of products will be presented using case studies.
Contact:
Peter Brown;     Phone: [410-501-5777];     Email: pbrown@fdamap.com
Topics:
FDA GMP Regulations, GMP Guidance, Good Manufacturing Practices, GMP, GMP Phase 1, Clinical Trials, Investigational New Drug, Process Validation, New Drug Development
Event listing ID:
1032078
10
Seminar — 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.
10 May 2018 - 11 May 2018 • New Brunswick, United States
Contact:
Conference Manager;     Phone: [844-267-7299];     Email: subscribe@worldcomplianceseminars.com
Event listing ID:
1053963
11
The Veterinary Drug Approval Process and FDA Regulatory Oversight
17 May 2018 - 18 May 2018 • Kansas City Marriott Country Club Plaza, MO, United States
Abstract:
The U.S. Food and Drug Administration’s Center for Veterinary Medicine or CVM is responsible for the approval of veterinary drug products intended for both family pets and food-producing animals. However, FDA does not regulate all products intended for animal use. Jurisdiction over animal products including licensed biologics such as vaccines is shared with a number of other federal agencies. For example, animal vaccines, animal disease diagnostic devices and some animal biologics are regulated by the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service or APHIS; and products such as flea and tick collars are regulated by the Environmental Protection Agency.
Event listing ID:
1046937
Related subject(s):
12
Scoop - Top Targets of Fed HIPAA Enforcers & Simple Steps to Take Control
18 May 2018 • online, United States
Contact:
Roger Steven;     Phone: [800-385-1607];     Email: support@mentorhealth.com
Topics:
hipaa standards, hipaa privacy and security rules, hipaa information, hipaa enforcement, hipaa covered entity, hipaa exemptions, hipaa privacy standards
Event listing ID:
1049813
13
CTS — 9th Annual Clinical Trials Summit 2018
22 May 2018 • Mumbai, India
Abstract:
Virtue Insight welcomes you to attend the 9th Annual Clinical Trials Summit 2018, which is going to be held in Mumbai on 22nd May 2018. We cordially invite all the participants who are interested in sharing their knowledge and research in the arena of Clinical Trials. 9th Annual Clinical Trials Summit 2018 anticipates participants around the globe with thought provoking Keynote lectures, Oral Presentations and Poster Presentations. This is an excellent opportunity for the delegates from Universities and Institutes to interact with the world class Scientists. The main theme of the conference is to positively learn and educate about clinical trials is essential, if only to counter more negative perceptions.
Contact:
Kavitha;     Phone: [+91 44 42108101];     Email: kavitha@virtueinsight.co.in
Topics:
clinical trials, pharma, data
Event listing ID:
1037018
Related subject(s):
14
CfPIE - The Center for Professional Innovation & Education — CMC Regulatory Compliance for Biopharmaceuticals & Biosimilars
23 May 2018 - 25 May 2018 • Berlin, Germany
Abstract:
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.
Contact:
Olivia Carlin;     Phone: [1-610-648-7550];     Email: info@cfpie.com
Topics:
compliance, biologics, FDA, EMA, regulatory review pathways, IND, NDA, BLA, MAA
Event listing ID:
1009952
Related subject(s):
15
CfPIE - The Center for Professional Innovation & Education — Preparing the CMC Section for MAAs, IMPDs
30 May 2018 - 31 May 2018 • Berlin, Germany
Abstract:
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).
Contact:
Olivia Carlin;     Phone: [1-610-648-7550];     Email: info@cfpie.com
Topics:
MAA, CTD, drug substance, purity, stability, DMF, Certificates of Suitability, CEP, CMC, chemistry manufacturing and controls
Event listing ID:
1009990
Related subject(s):
16
eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada
31 May 2018 - 01 Jun 2018 • DoubleTree by Hilton San Francisco Airport, CA, United States
Abstract:
This two day workshop will provide you with an in-depth review of the content and format requirements of the CTD/eCTD. Hands-on activities will include organizing specific study reports and other documents into the CTD, using tools for the project management of the CTD preparation, and pre-publishing an eCTD.
Event listing ID:
1046917
Related subject(s):
17
4th Annual ComplianceOnline Medical Device Summit 2018
07 Jun 2018 - 08 Jun 2018 • San Francisco, United States
Abstract:
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.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Event listing ID:
954518
18
HIPAA Privacy Rule Compliance-Understanding New Rules and Responsibilities of Privacy Officer
07 Jun 2018 - 08 Jun 2018 • DoubleTree by Hilton San Francisco Airport, CA, United States
Abstract:
With the recent implementation of new HIPAA regulations in the HIPAA Omnibus Update of 2013, healthcare organizations are reviewing their compliance and making sure they have the proper policies, procedures, and forms in place. HIPAA Privacy Officers have been renewing their compliance activities and reviewing their documentation to make sure they can meet the challenges of the new rules and avoid breaches and penalties for compliance violations.
Event listing ID:
1046905
Related subject(s):
19
Designing and Sustaining New and Existing Product Stability Testing Program
07 Jun 2018 - 08 Jul 2018 • Orlando, FL, United States
Abstract:
This seminar will provide a great resource to Pharmaceutical, Biotechnology, Diagnostics, Cell Therapy, Drugs, Biologics, OTC, Radio-pharmaceutical, Pharmacies and Medical Device Industries in understanding the effective way to establish a new or modified product stability testing program. This program is an important part of a product's regulatory filing requirements as well as the determination of the shelf life or expiration date of the product.
Event listing ID:
1046870
20
Gordon Research Seminar — Drug Safety
09 Jun 2018 - 10 Jun 2018 • Stonehill College, Easton, MA, United States
Topics:
Drug Safety in the Modern Development Landscape: Innovations from Industry, Academia, and Government
Event listing ID:
960000
21
Gordon Research Conference — Drug Safety
10 Jun 2018 - 15 Jun 2018 • Stonehill College, Easton, MA, United States
Topics:
Contemporary Advances and Challenges in Drug Safety Assessment
Event listing ID:
960067
22
Training — GDPR: Ensuring Legal Compliance in Health & Social Care Masterclass
12 Jun 2018 • London, United Kingdom
Abstract:
A Joint Healthcare Conferences UK & InPractice Training Course. This interactive masterclass will provide a legal guide to compliance with GDPR in health and social care. The training will be delivered by Kate Hill Solicitor InPractice. A 20% discount is available by quoting ref: hcuk20c-s when booking.
Contact:
8 Wilson Drive, Ottershaw, Surrey KT16 0NT;     Phone: 0044/1932 429933;     Email: kerry@hc-uk.org.uk
Topics:
Data Sharing, Data Protection, Information Sharing, Social Care, Legal
Event listing ID:
1050117
23
Clinical Trial Supply Chain Strategy Meeting US East Coast 2018
13 Jun 2018 • Boston, MA, United Kingdom
Abstract:
Proventa International’s unique format of Clinical Trial Supply Chain Strategy Meeting US East Coast 2018 gathers seasoned local and global thought leaders in an exclusive discussion where they talk about insights on shared challenges and come up with research-based solutions and new strategies. This year's Clinical Trial Supply Chain Strategy Meeting US East Coast will be held at Sheraton Boston Hotel in Boston MA on 13th June 2018.
Contact:
J. Perez;     Phone: [2070961222];     Email: jp@proventainternational.com
Topics:
biologics, clinical trial s supply chain, clinical supply chain, clinical trial management
Event listing ID:
1046673
24
How to Examine Critical Regulatory Requirements related to physician Practice Acquisitions
13 Jun 2018 • online, United States
Contact:
Roger Steven;     Phone: [8003851607];     Email: support@mentorhealth.com
Topics:
internal audit report writing, anti kickback statute, anti kickback law, stark law, stark violation, false claims act healthcare, healthcare anti kickback statute
Event listing ID:
1049884
25
Training — In-depth legal masterclass: Informed Consent
19 Jun 2018 • London, United Kingdom
Abstract:
This one-day course will cover all elements of informed consent as well as the law relating to treatment of those who lack capacity and who are unable to give informed consent. A 20% discount is available by quoting ref: hcuk20c-s when booking.
Contact:
8 Wilson Drive, Ottershaw, Surrey KT16 0NT;     Phone: 0044/1932 429933;     Email: kerry@hc-uk.org.uk
Topics:
Informed Consent, Law
Event listing ID:
1050153
26
2nd HBP Curriculum Workshop Series - ENTREPRENEURSHIP IN NEUROSCIENCE - TURNING SCIENCE INTO INVENTION & INNOVATION
04 Jul 2018 - 06 Jul 2018 • Berlin, Germany
Abstract:
This "hackathon" style workshop is a hands-on intensive experience complementing the theoretical aspects of the online course on Intellectual Property Rights, Translation and Exploitation of Research. Students will work in small multi-disciplinary teams to assemble joint applied research proposals in the wide range of fields in brain science. Experienced entrepreneurs, top executives at the interface between academia and industry and researchers from academia will present, mentor and advise on the translational aspects of the offered projects including how to advance their proposal from the lab to market, understand the problems and accordingly defining the needs in the chosen field, choosing or identifying the target population, patentability options and how to build a business model. Finally, they will present their proposals to industry and academy experts. The workshop is a unique experience of diving into the entrepreneurial world, learning how to incorporate innovation and entrepreneurship mindset and concepts into day-to-day research work and beyond.
Contact:
HBP Education Programme Office;     Email: curriculum.edu@humanbrainproject.eu
Topics:
Hackathon, entrepreneurship, invention, innovation, industry, research, academia, blue ocean strategy, product-market, interactive patents, data protection
Event listing ID:
1034648
27
2nd HBP Curriculum Workshop Series - RESEARCH, ETHICS AND SOCIETAL IMPACT DUAL USE AND RESPONSIBLE RESEARCH. ETHICAL CHALLENGES
04 Jul 2018 - 06 Jul 2018 • Berlin, Germany
Abstract:
This workshop aims to provide participants with insights on ethical aspects of dual-use research in neuroscience and Responsible Research and Innovation (RRI). Lectures will be given by some of the world's leading experts on dual-use in neuroscience research, and by active researchers on RRI. The topics covered will include the chemistry of the brain and dual action of drugs, novel incapacitants, ethics awareness and engagement and RRI. An important ingredient of the workshop is the use of team-based learning techniques.
Contact:
HBP Education Programme Office;     Email: curriculum.edu@humanbrainproject.eu
Topics:
Ethical aspects, dual-use, neuroscience, Responsible Research and Innovation, chemistry of the brain, dual action of drugs, novel incapacitant, ethics awareness, team-based learning
Event listing ID:
1034625
28
Seminar — 2 DAY SEMINAR Effective Compliance Strategies for Complaint Handling, Medical Device Reporting and Recalls
11 Jul 2018 - 12 Jul 2018 • Boston,MA, United States
Contact:
Conference Manager;     Phone: [844-267-7299];     Email: subscribe@worldcomplianceseminars.com
Event listing ID:
1053940
29
HACCP — Principles and Application of Hazard Analysis Critical Control Point
08 Aug 2018 - 09 Aug 2018 • New York, NY, United States
Abstract:
The Principles and Applications of HACCP course is designed to teach participants how to develop, implement and maintain a Hazard Analysis Critical Control Point (HACCP) system. The training is presented over 2 days which cover the 5 preliminary steps and the 7 principles of HACCP. Practical examples and activities are provided to assist with development and implementation within your food business. Additionally, participants will learn techniques for managing both HACCP and pre-requisite programs to ensure food products are safe and suitable for customers and consumers. This course is facilitated by an International HACCP Alliance qualified trainer with a certificate of competency provided to all participants who successfully complete the in-course activities and assessments.
Event listing ID:
1046989
30
Course — European Regulatory Procedures - EMA & National Requirements
13 Sep 2018 - 14 Sep 2018 • Berlin, Germany
Abstract:
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.
Contact:
Olivia Carlin;     Phone: [+1-610-648-7550];     Email: info@cfpie.com
Topics:
European Regulatory Procedures, Regulation, EMA, Centralised Procedure, European Medicines Agency, Filing Strategy, Labeling
Event listing ID:
1012417
Related subject(s):
31
The Pharma Licensing Negotiation Course
27 Sep 2018 - 28 Sep 2018 • Brussels, Belgium
Abstract:
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.
Contact:
Annelies Swaan;     Phone: [+32 2 709 01 42];     Email: annelies.swaan@celforpharma.com
Event listing ID:
1009955
32
IAMRA 2018 — 13th International Conference on Medical Regulation 2018
06 Oct 2018 - 09 Oct 2018 • Dubai, United Arab Emirates
Abstract:
Hosting the 13th International Association of Medical Regulatory Authorities is a reflection of Dubai’s capabilities in being a home to such a prominent event.
Contact:
Phone: [43116300];     Email: nida.nafis@mci-group.com
Event listing ID:
1036624
Event website:
33
Seminar — 2018 Data Integrity Seminar : FDA/EU Requirements and Implementation
11 Oct 2018 - 12 Oct 2018 • Boston,MA, United States
Contact:
Conference Manager;     Phone: [844-267-7299];     Email: subscribe@worldcomplianceseminars.com
Event listing ID:
1053983
34
Course — Filing Variations in the European Union
07 Nov 2018 - 08 Nov 2018 • Berlin, Germany
Abstract:
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.
Contact:
Olivia Carlin;     Phone: [+1-610-648-7550];     Email: info@cfpie.com
Topics:
filing, extensions, Marketing Authorizations, filing variations, CMD, Submission, Timeline
Event listing ID:
1012495
35
Euro toxi summit 2018 — Euro Summit on Toxicology & Pharmacology
19 Nov 2018 - 21 Nov 2018 • Rome, Italy
Abstract:
Scient Open Access extends an enthusiastic and sincere welcome to the Euro Summit on Toxicology & Pharmacology which is set to hit the calendar in November 19-21 at Rome, Italy. The Euro Toxicology Conference is the nation’s biggest, most influential collaboration of professionals dedicated to Toxicology & Pharmacology.
Contact:
jessie reyes;     Phone: [15199000130];     Email: genotoxicology@scientonline.org
Topics:
Scientific Sessions Track 1 Toxicology Track 2 Applied Toxicology Track 3 Drug Toxicology Track 4 Pharmacology and Toxicology Track 5 Environmental Toxicology Track 6 Immunotoxicology Track 7 Applied Pharmacology Track 8 Forensic Toxicology Track 9 Reproductive Toxicology Track 10 Genetic Toxicology Track 11 Toxicology Current Advances Track 12 Industrial & Occupational Toxicology Track 13 Trending Toxicology Concepts Track 14 Computational toxicology Track 15 Clinical Pharmacology Track 16 Cardiovascular Pharmacology
Event listing ID:
1053270
36
The Pharmaceutical Out-licensing Course
27 Nov 2018 - 28 Nov 2018 • Brussels, Belgium
Abstract:
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.
Contact:
Annelies Swaan;     Phone: [+32 2 709 01 42];     Email: annelies.swaan@celforpharma.com
Event listing ID:
1009932


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Last updated: 22 April 2018