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Searching Content by Chiang Ling Li from Jones Day ordered by Published Date Descending.
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1
Jones Day Global Privacy & Cybersecurity Update | Vol. 21
Data privacy- and security-related class actions appear to be on the rise, and effectively defending them requires the right mix of substantive and procedural knowledge.
Worldwide
11 Mar 2019
2
China's New Cybersecurity Law Brings Enforcement Crackdown
Even before its enactment on June 1, 2017, the Cybersecurity Law of the People's Republic of China ("Cybersecurity Law") sparked outcry from the international community.
China
19 Oct 2017
3
Implementing China's Cybersecurity Law
China's Cybersecurity Law came into effect on June 1, 2017. Three months later, many uncertainties remain as only some of the anticipated implementing regulations have been issued.
China
5 Sep 2017
4
China's New Cybersecurity Law And Draft Data Localization Measures Expected To Burden Multinational Companies
China's new Cybersecurity Law ("new Law") is set to come into effect on June 1, 2017, and introduces sweeping provisions that may have a significant impact on companies doing business in and with China.
China
10 May 2017
5
EMA Updates Organizational Structure
It is not anticipated that interactions between stakeholders and the Agency will be affected by these changes.
European Union
29 Sep 2016
6
EMA Consults On Development Of Medicines To Treat Tuberculosis
The guidance is an addendum to EMA's guideline on the evaluation of medicines to treat bacterial infections.
European Union
29 Sep 2016
7
EMA Consults On Modeling And Simulation In The Development And Regulatory Review Of Medicines
EMA has published a draft guideline to support and guide the use of innovative modeling and simulation approaches that are currently being used during the development of medicines.
European Union
29 Sep 2016
8
Proposals To Revise Guidance On First-In-Human Clinical Trials
EMA is proposing changes to current guidance on first-in-human clinical trials with the aim of improving strategies to identify and mitigate risks to trial participants.
European Union
28 Sep 2016
9
EMA Publishes Report On Adaptive Pathways Pilot Project
EMA has published a final report on the experience gained during its pilot project on adaptive pathways, a product development concept for medicines that address patients' unmet medical needs.
European Union
28 Sep 2016
10
European Commission Publishes Revised Medical Device Guidance On Stand-Alone Software
The European Commission has published a revised version of its Guidelines on Qualification and Classification of Stand-Alone Software ("MEDDEV 2.1/6"), which replaces the earlier 2012 version.
European Union
28 Sep 2016
11
New EMA Guidance On Data Integrity
EMA has released new good manufacturing practice guidance aimed at ensuring the integrity of data generated in the process of testing, manufacturing, packaging, distributing, and monitoring medicines.
European Union
28 Sep 2016
12
UK's MHRA Issues Guidance On Health Apps
On August 25, 2016, MHRA issued updated guidance to help identify the health apps that are medical devices and make sure they comply with regulations and are acceptably safe.
UK
28 Sep 2016
13
UK's MHRA Launches FakeMeds Campaign With Warning On Diet Pills
The campaign provides practical information on how to recognize legitimate online retailers of medicines and medical devices.
UK
27 Sep 2016
14
French ANSM Issues Guidance On Pilot Phase Clinical Trials
The purpose of the pilot phase is to ensure that France is ready when the European Regulation comes into force.
European Union
27 Sep 2016
15
EMA Workshop On Genetically Modified T-Cells
People interested in participating are invited to register using the form available on the website.
European Union
27 Sep 2016
16
New EMA Guidelines On Good Pharmacovigilance Practices
The GVP guidance was effective on August 16, 2016.
European Union
27 Sep 2016
17
EU And US eHealth IT Roadmap
The foreseen activities for this new work stream are outlined in the annex to the roadmap and will start in fall/autumn 2016.
Worldwide
27 Sep 2016
18
FDA To Host Public Conference On Key Aspects Of Drug And Device Regulations
The meeting will be available via webcast, but there will not be a transcript available following the meeting.
United States
27 Sep 2016
19
FDA Proposes Expanding Scope Of Clinical Investigator Disqualification In Regulations For New Animal Drugs For Investigational Use
With this proposal, FDA intends to help ensure adequate protection of animal research subjects and the quality and integrity of data submitted to FDA.
United States
27 Sep 2016
20
FDA Proposes Revising Regulations For Good Laboratory Practice For Nonclinical Laboratory Studies
A GLP Quality System will provide the appropriate framework for building quality into a nonclinical laboratory study and will result in more reliable data for FDA to consider when making regulatory decisions.
United States
27 Sep 2016
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