Editorial Calendar

2015 Editorial Calendar

Definition of Risk
Manuscripts Due: 22 August 2014 Publishes: 26 January 2015
Specific topics could include: General approach to risk in accordance with QRM (ICHQ9); risk assessments - prospective vs. retrospective; risk as a function of product lifecycle; if a risk is mitigated by a control is it still a risk?; and retrospective risks – legacy products.
Risks Associated with Product Development and Pharmaceutical Manufacturing
Manuscripts Due: 29 October 2014 Publishes: 23 March 201
Specific topics could include: risks associated with supply chain complexity; residual risk;minimizing risk through introduction of RTRt, continuous processing, etc.; and managing risks for expedited regulatory submissions – breakthrough therapy designation.
Risks Associated with Manufacturing Facilities
Manuscripts Due: 8 January 2015 Publishes: 25 May 2015
Specific topics could include: how manufacturing plant design can mitigate risk?; and mitigation of Risks for Sterile Manufacture.
Risks Associated with Pharmaceutical Quality Systems
Manuscripts Due: 11 March 2015 Publishes: 27 July 2014
Specific topics could include: lifecycle change management; knowledge management – risk assessments; site transfers; and quality metrics.
Risks Associated with Product Performance
Manuscripts Due: 7 May 2015 Publishes: 21 September 2015
Specific topics could include: risks and absence of biorelevance; patient compliance, product compatibility and in-use; and devices.
Risk-Based Regulatory Review
Manuscripts Due: 9 July 2015 Publishes: 23 November 2015
Specific topics could include: benefit vs. risk; clinically relevant specifications; comprehensive control strategy; and regulatory commitments and post approval change management protocols

2014 Editorial Calendar 

January/February 2014
Cover Story/Lead Article: Evolving Technologies, Regulations, and Processes in Biotechnology
Manuscripts Due: 23 August 2013 Publishes: 20 January 2014


March/April 2014
Cover Story/Lead Article: Trends in Pharmaceutical Quality Management
Manuscripts Due: 31 October 2013 Publishes: 24 March 2014


May/June 2014
Cover Story/ Lead Article: Complexity and Risk in the Global Supply Chain
Manuscripts Due: 8 January 2014 Publishes: 26 May 2014


July/August 2014
Cover Story/Lead Article: Next Generation Manufacturing
Manuscripts Due: 6 March 2014 Publishes: 21 July 2014


September/October 2014
Cover Story/Lead Article: Quality Metrics in Pharmaceutical Manufacturing
Manuscripts Due: 8 May 2014 Publishes: 22 Sep 2014


November/December 2014
Cover Story/Lead Article: Risk Management Strategies when Outsourcing
Manuscripts Due: 9 July 2014 Publishes: 24 Nov 2014