Planned for January 2019
Pierre Mermet-Bouvier
eCOAs I Regulatory Affairs I Transparency I PMO I Regulatory Intelligence I Clinical Operations I Global and Transversal Teams I Process Improvement I Operational Excellence I Strategic Planning
If you are working or involved in Clinical Trials…
Here a list of key events or documents expected in January 2019 that may be of interest to you:
On specific dates :
01Jan19 : ICMJE : Clinical trials that begin enrolling participants on or after 1 January 2019 must include a Data Sharing Plan in the trial’s registration.
01Jan19 : The use the eCTD format will be mandatory for all regulatory activities in National Procedures (NP) by 1 January 2019 (mandatory for new national MAAs since 01Jul18).
01Jan19 : The PIC/S Committee adopted a new "Guidance on Classification of GMP Deficiencies (PI 040-1)" as mentioned in the press release of the PIC/S Meetings in Chicago (Sep18). The Guidance was scheduled to enter into force on 01Jan19, but it still not available in the PIC/S Web site today. The purpose and scope of this guidance is the harmonisation of the classification of GMP deficiencies to facilitate harmonised reporting of GMP deficiencies from inspections across inspectorates. It is planned in the future that its scope will be further extended also to Good Distribution Practice (GDP) deficiencies.
21Jan19 : This is the effective and general compliance date of the revised Common Rule from the U.S. Department of Health and Human Services and fifteen other Federal Departments/Agencies following the delay for an additional 6-month period.
https://www.govinfo.gov/content/pkg/FR-2018-06-19/pdf/2018-13187.pdf
25Jan19 : This is the first of the three public meetings organized by FDA on ? Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting System (FAERS) using International Council for Harmonisation (ICH) E2B(R3) Standards ?.
28jan19 : This is Data Privacy Day. The choice of the 28Jan for the Data Privacy Day is coming from the ? Convention for the Protection of Individuals with regard to Automatic Processing of Personal Data ?, that was developed by the Council of Europe in Strasbourg. The Convention opened for signature on 28 January 1981 and was the first legally binding international instrument in the data protection field. It was amended in May18.
In January :
- The FDA CDER & CBER respective ? Guidance Agendas : Guidances CDER or CBER is planning to develop during Calendar Year 2019 ? are planned to be published (CDRH Proposed Guidance Development was released in 4Q18 already ;-))
- The FY 2018 Inspectional Observation Summaries (Number of 483s Issued from the System) will be available into https://www.fda.gov/ICECI/Inspections/ucm250720.htm
Early 2019 :
- The french Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) will create a third Clinical Trial Fast Track beginning of 2019. This new one will be specific for Cell and Gene Therapies.
- This will be the EMA move and installation in Amsterdam into the SPARK building (temporary building) that should be fully operational the 01Jan19.
End of Public consultations in January :
11Jan19 : End of EU Commission Public consultation on the legislation on medicines for children and rare diseases launched in Oct18:
https://ec.europa.eu/info/law/better-regulation/initiatives/ares-2017-6059807/public-consultation_en
14Jan19 : End of FDA public consultation on the proposed rule on Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations: https://www.govinfo.gov/content/pkg/FR-2018-11-15/pdf/2018-24822.pdf
18Jan19 : End of Public consultation from the European Data Protection Board (EDPB) on the Guidelines 3/2018 on the territorial scope of the GDPR (Article 3).
Unless I missed something, nothing was published by the EU Commission in 2018 following the end of the public consultation a year ago (31Jan18) on the 19-page Draft "Reflection paper on the pharmaceutical development of medicines for use in the older population".
Anniversary (Non exhaustive list):
4 years ago : The major 249 pages "Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk report" from the US Institute of Medicine" document was published mid Jan15.
4 years ago : An electronic repository for Periodic Safety Update Reports (PSURs) and their assessment reports was launched by the European Medicines Agency (EMA) on 26jan15. This central platform was created in accordance with the pharmacovigilance legislation of the European Union, to contain all information related to PSURs in the EU, & to facilitate assessment of medicines safety reports.
5 years ago : EFPIA/PhRMA Joint Principles for Responsible Clinical Trial Data Sharing were implemented on 01Jan14.
10 years ago : The European Medicines Agency (EMEA) announced the formal creation of its sixth scientific committee, the Committee for Advanced Therapies (CAT), which met for the first time on 15Jan09.
10 years ago : The 26Jan09, Pfizer acquired Wyeth, creating the World's Premier Biopharmaceutical Company at that time.