Expanding Industry Knowledge

Publications

Katz NR and Wood LF. Katz, NR and Wood LF. A pilot survey of strategies for the development of clinical summary documents. AMWA Journal. 2017; 32(1): 3-11.

Clemow DB, Wagner B, Marshallsay C, Benau D. L’Heureux D, Brown D, Ghosh D, Girten E, Hubbard F, Gawrylewski H, Hiroko E, Stoltenborg J, York JP, Green K, Wood LF, Toth L, Mihm M, Katz, NR, Vasconcelos NM, Sakiyama N, Whitsell R, Gopalakrishnan S, Bairnsfather S, Wanderer T, Schindler TM, Mikyas Y, Aoyama Y. Medical Writing Competency Model –Section 1: Functions, Tasks, and Activities. 2017. DOI: 10.1177/2168479017721585, tirs.sagepub.com. Medical Writing Competency Model – Section 2: Knowledge, Skills, Abilities, and Behaviors. 2017. DOI: 10.1177/2168479017723680 tirs.sagepub.com.

Katz NR. Q & A to E3: A must-read for regulatory writers. AMWA Journal. 2012. Volume 24 (4); 158-159.

Katz NR. Effective eCTD Writing: Five essential competencies. Global Forum. 2011 April;3(2):27-31.

Wood L, Foster MH, Averback J, Boe P, Katz, NR. Topic-based authoring: a content management paradigm for accurate, consistent regulatory documents. Drug Information Journal. 2011 March;45:(2)125-129.

Katz, NR. The eCTD: A primer and beyond for regulatory writers. DIA Global Forum. 2010 April;(2):16-22.

Katz, NR. Your career as biopharmaceutical regulatory writer in Choosing the Right Regulatory Career, edited by Peggy Berry. Maryland: RAPS; 2010, and available at: Click to view