Conferences and Meetings on Regulation in Medicine and Pharmacology

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India (2) - Switzerland (1) - United Kingdom (6) - United States (25)

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1
Clinical Trial Regulatory Requirements
25 Jan 2018 - 26 Jan 2018 • London, United Kingdom
Abstract:
This course will take you through the key regulatory and guideline requirements for clinical research in Europe, including the new EU Clinical Trial Regulation and existing Directive requirements. Key US requirements which impact on trials being carried out in Europe will also be briefly covered.
Event listing ID:
952486
Related subject(s):
2
RMPS — A Practical Guide to Writing Risk Management Plans
29 Jan 2018 • London, United Kingdom
Abstract:
The new Pharmacovigilance Legislation of 2012 now requires companies to provide Risk Management Plans ( RMP s) and assessments for all new products whether those products are generic products or new chemical entities. If these are not done correctly this can delay both licensure and sales and damage the Company ability to maximise its products. Maintenance of the  RMP s also is an important aspect for maintaining the licence, compliance and these are reviewed in Regulatory Inspections. Can you afford not to get this right?
Event listing ID:
952474
3
A Practical Guide to Producing and Maintaining the PSMF
30 Jan 2018 • London, United Kingdom
Abstract:
This course will be relevant for anyone requiring a comprehensive overview of the Pharmacovigilance function and duties. It may be of particular interest to those who are responsible in Pharmacovigilance for any safety assessments and writing such plans including any EU QP PVs who approve such documents. Those who work with pharmacovigilance, e.g. Regulatory Affairs, Clinical, Sales & Marketing, Legal, Commercial and Quality and IT that must sign off such documents.
Event listing ID:
957176
4
Workshop — 2 Days Workshop:FDA Penalties for Regulatory Non-Compliance in the Pharmaceuticals Industry - 2017 in Review
30 Jan 2018 • San Diego, United States
Contact:
Conference Manager;     Phone: [347 282-5400];     Email: support@worldcomplianceseminars.in
Event listing ID:
974021
5
REMS — An Introduction to Risk Evaluation & Mitigation Strategies
31 Jan 2018 • London, United Kingdom
Abstract:
The course will provide insight into the  FDA  thinking of which products qualify for a Risk Evaluation and Mitigation Strategies ( REMS ), the different categories of  REMS, their introduction and maintenance and the reporting assessments on the  REMS
Event listing ID:
957130
6
How to Validate for Regulated Computer Systems
02 Feb 2018 • Fremont, United States
Abstract:
You'll learn about the various computer system validation deliverables and how to document them through the entire process. You will learn about what must be done to ensure the system remains in a validated state.
Contact:
Event Manager;     Phone: [18004479407];     Email: support@compliance4All.com
Topics:
medical trainings, Compliance trainings, healthcare trainings, Online trainings
Event listing ID:
978944
7
How to Compliance with SaaS/Cloud Software Applications
05 Feb 2018 • Fremont, United States
Abstract:
It gets you on the right track for using electronic records and signatures to greatly increase productivity and ensure compliance.
Contact:
Event Manager;     Phone: [18004479407];     Email: support@compliance4All.com
Topics:
medical trainings, Compliance trainings, healthcare trainings, Online trainings
Event listing ID:
978921
8
Postgraduate Course in Clinical Pharmacology, Drug Development and Regulation
05 Feb 2018 - 09 Feb 2018 • Boston, United States
Abstract:
Tufts CSDD’s highly acclaimed, CME accredited, five-day Postgraduate Course in Clinical Pharmacology, Drug Development and Regulation provides advanced instruction in practical and technical problem-solving in the areas of clinical pharmacology, drug development & clinical trial strategies, biopharmaceutical development, drug safety, and new drug regulation.

The course is designed to provide students with a broad and comprehensive understanding of issues related to the development and regulation of drugs, biologics, vaccines, devices, and in vitro diagnostics. Lectures focus on basic drug development topics - such as translational medicine, clinical pharmacology, epidemiology, drug regulation, and adverse drug event reporting - as well as broader - such as pharmacoeconomics, drug-device combinations, biosimilars, working with investigative sites, and drug marketing.

Educational Objectives for CME - at the conclusion of the activity, participants will be able to:

Clinical Pharmacology: Integrate the relevant pharmacology, pharmacokinetics, and statistics related to drug development and the nature of evidence required for proof of efficacy and safety.

Drug Development and Clinical Trials: Using a case-study approach, identify and solve practical, theoretical, and technical problems in human drug studies, and analyze an experimental design for a new drug candidate.

Regulation: Evaluate the science, laws, and regulations pertaining to the development and review of new drug products in the USA, Europe, Japan and other pharmaceutical markets.

*Groups of 3 or more receive discounted rates.

Contact:
Center for the Study of Drug Development (CSDD);     Phone: [617-636-2170];     Email: csdd@tufts.edu
Topics:
Drug development, pharmacy, pharmacology, medicine, drug regulation, clinical research, clinical trials, academic, professional development
Event listing ID:
950851
9
How to Accurate Adverse Event Reporting
06 Feb 2018 • Fremont, United States
Abstract:
Learn why the single most important function of the Principal Investigator and the study conduct team is the awareness, assessment, and management of Adverse Events occurring during the conduct of clinical research with drugs or devices utilizing human subjects.
Contact:
Event Manager;     Phone: [18004479407];     Email: support@compliance4All.com
Topics:
medical trainings, Compliance trainings, healthcare trainings, Online trainings
Event listing ID:
978931
10
Why Capturing Justifications in Change Control
07 Feb 2018 • Fremont, United States
Abstract:
It is easy to document what process has been performed, what has been investigated or changed or why something is a risk, but the difficult part is knowing how to explain or justify why it should be done or why a product should be released or rejected as a result.
Contact:
Event Manager;     Phone: [18004479407];     Email: support@compliance4All.com
Topics:
medical trainings, Compliance trainings, healthcare trainings, Online trainings
Event listing ID:
979029
11
Practices for Active Pharmaceutical Ingredients per ICH Q7
08 Feb 2018 • Fremont, United States
Abstract:
The APIs covered in this guidance document include new chemical entities and APIs of biological origin and those created by biotech processes.
Contact:
Event Manager;     Phone: [18004479407];     Email: support@compliance4All.com
Topics:
medical trainings, Compliance trainings, healthcare trainings, Online trainings
Event listing ID:
979006
12
How to plan risk based approaches for clinical trials
12 Feb 2018 • Fremont, United States
Abstract:
You will understand how to identify, evaluate and also how to implement specific risk based techniques for risk management used in clinical trials.
Contact:
Event Manager;     Phone: [18004479407];     Email: support@compliance4All.com
Topics:
medical trainings, Compliance trainings, healthcare trainings, Online trainings
Event listing ID:
979027
13
Final Rules of Unique Device Identification
14 Feb 2018 • Fremont, United States
Abstract:
This webinar will address the four key steps to compliance by device manufacturers. Also covered will be the Final Rule's provisions to address existing FG inventory, not properly labeled.
Contact:
Event Manager;     Phone: [18004479407];     Email: support@compliance4All.com
Topics:
medical trainings, Compliance trainings, healthcare trainings, Online trainings
Event listing ID:
978971
14
How to Comply with both in the Same Organization
16 Feb 2018 • Fremont, United States
Abstract:
This ISO 13485:2016 webinar is a standard for Quality Management Systems of medical device manufacturers and suppliers, and is used worldwide for developing and maintaining the system that caters to the needs of the market requirements for medical devices.
Contact:
Event Manager;     Phone: [18004479407];     Email: support@compliance4All.com
Topics:
medical trainings, Compliance trainings, healthcare trainings, Online trainings
Event listing ID:
979047
15
Underutilized and Underappreciated in Management Control
21 Feb 2018 • Fremont, United States
Abstract:
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.
Contact:
Event Manager;     Phone: [18004479407];     Email: support@compliance4All.com
Topics:
medical trainings, Compliance trainings, healthcare trainings, Online trainings
Event listing ID:
979079
16
Learn Some of the Acceptance Activities in FDA QSR
21 Feb 2018 • Fremont, United States
Abstract:
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.
Contact:
Event Manager;     Phone: [18004479407];     Email: support@compliance4All.com
Topics:
medical trainings, Compliance trainings, healthcare trainings, Online trainings
Event listing ID:
979001
17
Workshop — 2 Day Workshop: Preparing For The New EU Medical Device Regulations (MDR)
21 Feb 2018 - 22 Feb 2018 • Hollywood, United States
Contact:
Conference Manager;     Phone: [347 282-5400];     Email: support@worldcomplianceseminars.in
Event listing ID:
974020
18
Training — Information Governance in Health and Social Care: Ensuring Compliance with GDPR
23 Feb 2018 • London, United Kingdom
Abstract:
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.
Contact:
8 Wilson Drive, Ottershaw, Surrey KT16 0NT;     Phone: 0044/1932 429933;     Email: kerry@hc-uk.org.uk
Topics:
Social Care, Data Sharing, Data Protection, Information Sharing
Event listing ID:
979516
19
NDAs and INDs for Orally-Administered Drug Products
28 Feb 2018 • Fremont, United States
Contact:
Event Manager;     Phone: [18004479407];     Email: support@compliance4All.com
Topics:
medical trainings, Compliance trainings, healthcare trainings, Online trainings
Event listing ID:
979088
20
How Ensuring Data Integrity in Method Validations
28 Feb 2018 • Fremont, United States
Abstract:
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.
Contact:
Event Manager;     Phone: [18004479407];     Email: support@compliance4All.com
Topics:
medical trainings, Compliance trainings, healthcare trainings, Online trainings
Event listing ID:
979032
21
Workshop — 2018 : 2 Days Conference on UnAnnounced Audits are You Prepared?
08 Mar 2018 - 09 Mar 2018 • Ahmedabad, India
Abstract:
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.
Contact:
Conference Manager;     Phone: [347 282-5400];     Email: support@worldcomplianceseminars.com
Event listing ID:
1003026
22
Workshop — 2 Day Workshop: FDA Inspections: What Regulators Expect and How to Prepare
14 Mar 2018 - 15 Mar 2018 • San Diego, United States
Contact:
Conference Manager;     Phone: [347 282-5400];     Email: support@worldcomplianceseminars.in
Event listing ID:
974118
23
Pharma Regulatory 2018
15 Mar 2018 • Mumbai, India
Abstract:
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.
Contact:
Kavitha;     Phone: [+91 44 64998743];     Email: kavitha@virtueinsight.co.in
Event listing ID:
981940
24
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 Mar 2018 - 16 Mar 2018 • Hollywood, United States
Contact:
Conference Manager;     Phone: [347 282-5400];     Email: support@worldcomplianceseminars.in
Event listing ID:
974139
25
FDA's Medical Device Software Regulation Strategy
20 Mar 2018 - 21 Mar 2018 • Zurich, Switzerland
Abstract:
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 < GET20 > and get 20% off on registration and this offer is not valid for with stay registration.
Contact:
Referral;     Phone: [8887172436];     Email: referral@complianceonline.com
Topics:
Seminar by Ex-FDA Official, Regulatory profile for software products, FDA mobile apps regulation, medical device software functionality, FDA and NIST software guidance
Event listing ID:
969736
26
Workshop — 1 Day workshop GMP’s in practice: quality systems, common sense compliance, and application
22 Mar 2018 • Washington D.C, United States
Abstract:
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).
Contact:
Conference Manager;     Phone: [347 282-5400];     Email: support@worldcomplianceseminars.com
Event listing ID:
1003058
27
The FDA Drug Approval Process
22 Mar 2018 - 23 Mar 2018 • London, United Kingdom
Abstract:
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.
Event listing ID:
956642
28
2nd Interim Analysis Symposium (EXL)A
26 Mar 2018 - 27 Mar 2018 • Philadelphia, PA, United States
Abstract:
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.
Event listing ID:
957038
Related subject(s):
29
2nd Product Complaints Forum (EXL)A
26 Mar 2018 - 27 Mar 2018 • Philadelphia, PA, United States
Abstract:
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.
Event listing ID:
956993
Related subject(s):
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 • Boston, United States
Contact:
Conference Manager;     Phone: [347 282-5400];     Email: support@worldcomplianceseminars.in
Event listing ID:
974094
31
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:
1003001
32
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:
954452
33
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
34
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


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AIP Conference Proceedings
AIP Conference Proceedings
Last updated: 17 December 2017